HYDRAJAGWIRE

Report

Report Number: 3005099803-2011-02565
Event Type: Death
Date Received: July 26, 2011
Date of Event: July 6, 2011
Report Date: July 6, 2011
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA
Product Code: EZB
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION: ALTHOUGH THE EXACT DATE OF DEATH IS UNKNOWN, THE PATIENT DEATH OCCURRED BETWEEN (B)(6) 2011. ADDITIONAL INFORMATION A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE URETHANE SECTION OF THE DREAM END TIP WAS COMPLETELY MISSING, THE DEVICE WAS SLIGHTLY SCRAPPED AT THE DISTAL SECTION AND REMNANTS OF ADHESIVE WERE FOUND INDICATING THAT THE URETHANE WAS PROPERLY ATTACHED TO THE COREWIRE. THE PTFE JACKET SHOWED EVIDENCE OF BEING DAMAGED, EXPOSING THE CORE WIRE, IN ADDITION THE DEVICE WAS FOUND TO BE KINKED IN TWO LOCATIONS. THE DEVICE APPEARS TO HAVE BEEN IN CONTACT WITH A SHARP OR METAL OBJECT IT IS POSSIBLE THAT UNSTATED PROCEDURE AND POSSIBLY CLINICAL FACTORS (TORTUOUS ANATOMY) MAY HAVE CONTRIBUTED TO THE DAMAGES FOUND IN THE GUIDEWIRE, INCLUDING BUT NOT LIMITED TO INTERACTION WITH OTHER DEVICES, HANDLING OF THE DEVICE AND CONDITION OF THE TREATED LESION (HEAVY DUODENAL STENOSIS) AS PER ADDITIONAL INFORMATION IT IS IMPORTANT TO NOTE THAT THE DOCTOR SPECIFIED THAT THE DEATH WAS CAUSED BY PRIMARY DISEASE (PANCREATIC CANCER) AND PERITONITIS. THE PERFORATION OCCURRED WAS RELATED TO THE HYDRA JAGWIRE, TANDEM AND CRE BALLOON AND THAT THERE IS NOT ENOUGH INFORMATION TO DETERMINE IF THE GUIDEWIRE USED CAUSED THE PERFORATION. ADDITIONALLY THE REMNANTS OF ADHESIVE FOUND INDICATE THAT THE POLY TIP WAS PROPERLY ATTACHED TO THE COREWIRE; THEREFORE, "OPERATIONAL CONTEXT" IS THE MOST PROBABLE ROOT CAUSE FOR THIS INCIDENT. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND.

Additional Manufacturer Narrative · 1

(B)(4) - THE REPORTED EVENT OF TIP DETACHMENT. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2011-02565 AND MFR. REPORT # 3005099803-2011-02619). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA-JAGWIRE GUIDEWIRE AND A WALLFLEX ENTERAL DUODENAL STENT WERE USED DURING A STENT PLACEMENT PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A SEVERE STRICTURE WITHIN THE DUODENUM AS A RESULT OF PANCREATIC CANCER. THE HYDRA-JAGWIRE GUIDEWIRE (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02565) WAS ADVANCED THROUGH THE STRICTURE AND POSITIONED AT THE DESIRED SITE. AT THIS TIME, IT WAS NOTED THAT THE GUIDEWIRE HAD BENT INTO A "C" SHAPE. THE WALLFLEX ENTERAL DUODENAL STENT SYSTEM (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02619) WAS ADVANCED OVER THE GUIDEWIRE. HOWEVER, AS THE STENT SYSTEM WAS POSITIONED AT THE STRICTURE, THE HYDROPHILIC COATING OF THE GUIDEWIRE PEELED OFF. THE GUIDEWIRE WAS WITHDRAWN AND INSPECTED. IT WAS REPORTED THAT THE CORE OF THE WIRE APPEARED TO BE INTACT. THE COATING FRAGMENTS WERE LEFT WITHIN THE PATIENT AT THE DISTAL END OF THE STRICTURE. THE PHYSICIAN DID NOT EXPRESS CONCERN OVER LEAVING THE COATING FRAGMENTS WITHIN THE PATIENT AND DETERMINED THAT THE FRAGMENTS WOULD PASS NATURALLY WITHOUT CAUSING HARM TO THE PATIENT. IN THE PHYSICIAN'S ASSESSMENT, THE GUIDEWIRE COATING DETACHED MOST LIKELY DUE TO THE TORTUOUS ANATOMY. THE PHYSICIAN THEN INSERTED THE OTHER END OF THE SAME HYDRA-JAGWIRE GUIDEWIRE INTO THE PATIENT TO COMPLETE THE PROCEDURE. THE WALLFLEX ENTERAL DUODENAL STENT WAS SUCCESSFULLY DEPLOYED ACROSS THE STRICTURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DURING THE STENT PLACEMENT PROCEDURE. ON (B)(6) 2011, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT HAD PASSED AWAY. THE DATE OF DEATH WAS NOT PROVIDED. IN THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF DEATH WAS A RESULT OF THE PANCREATIC CANCER AND PERITONITIS. IN ADDITION, A PERFORATION WAS DETECTED IN THE DUODENUM. IN THE PHYSICIAN'S ASSESSMENT, THE PERFORATION MAY HAVE BEEN A CAUSED BY THE HYDRA-JAGWIRE GUIDEWIRE OR THE DELIVERY CATHETER OF THE WALLFLEX STENT DURING THE INITIAL STENT PLACEMENT PROCEDURE. **ADDITIONAL INFORMATION RECEIVED SINCE (B)(6) 2011** THIS REPORT IS ONE OF FOUR COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # 3005099803-2011-02565, MFR. REPORT # 3005099803-2011-02619, MFR. REPORT # 3005099803-2011-02800, AND 3005099803-2011-02836.) DURING THE PROCEDURE ON (B)(6) 2011, THE HYDRA-JAGWIRE GUIDEWIRE (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02565) AND THE TANDEM ERCP CANNULA (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02800) WERE INSERTED INTO THE INTESTINAL TRACT. HOWEVER, DURING POSITIONING, THE GUIDEWIRE AND CANNULA PERFORATED THE INTESTINAL WALL. THE PERFORATION WAS NOT DETECTED AT THIS TIME. A CRE BALLOON DILATATION CATHETER (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02836) WAS USED TO DILATE THE ANATOMY. NO VISIBLE ISSUES WERE NOTED TO THE BALLOON AND NO FUNCTION ISSUES WERE EXPERIENCED DURING DILATATION. PRIOR TO THE STENT PLACEMENT, THE PERFORATION WAS DETECTED VIA X-RAY. IN THE PHYSICIAN'S ASSESSMENT, THE PERFORATION WAS CAUSED BY THE GUIDEWIRE AND THE CANNULA. THE BALLOON DILATION EXACERBATED THE PERFORATION. AS THE PERFORATION WAS DETECTED PRIOR TO STENT PLACEMENT, THE STENT DID NOT CAUSE OR CONTRIBUTE TO THE PERFORATION. IN THE PHYSICIAN'S ASSESSMENT, THERE WAS NO MALFUNCTION OF THE STENT. THE FOLLOWING DAY, THE PATIENT DEVELOPED PERITONITIS. POOLING OF AIR WAS NOTED IN THE ABDOMINAL CAVITY AND THE PERFORATION WAS CONFIRMED BY X-RAY IMAGE AND CT SCAN. THE PHYSICIAN CONSIDERED AN OPERATION FOR THE PERITONITIS AND CONSULTED WITH THE PATIENT'S FAMILY, BUT CHOSE NOT TO PERFORM THE OPERATION AS THE PATIENT WAS AT AN ADVANCED AGE. SO, THE PHYSICIAN CHOSE CONSERVATIVE MANAGEMENT AND ADMINISTERED ANTIBIOTICS TO TREAT THE PERITONITIS. BETWEEN (B)(6) 2011, THE PATIENT PASSED AWAY. THE EXACT DATE OF DEATH IS UNKNOWN. AN AUTOPSY WAS NOT PERFORMED.

Description of Event or Problem · 1

NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2011-02565 AND MFR. REPORT # 3005099803-2011-02619). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA-JAGWIRE GUIDEWIRE AND A WALLFLEX ENTERAL DUODENAL STENT WERE USED DURING A STENT PLACEMENT PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A SEVERE STRICTURE WITHIN THE DUODENUM AS A RESULT OF PANCREATIC CANCER. THE HYDRA-JAGWIRE GUIDEWIRE (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02565) WAS ADVANCED THROUGH THE STRICTURE AND POSITIONED AT THE DESIRED SITE. AT THIS TIME, IT WAS NOTED THAT THE GUIDEWIRE HAD BENT INTO A "C" SHAPE. THE WALLFLEX ENTERAL DUODENAL STENT SYSTEM (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02619) WAS ADVANCED OVER THE GUIDEWIRE. HOWEVER, AS THE STENT SYSTEM WAS POSITIONED AT THE STRICTURE, THE HYDROPHILIC COATING OF THE GUIDEWIRE PEELED OFF. THE GUIDEWIRE WAS WITHDRAWN AND INSPECTED. IT WAS REPORTED THAT THE CORE OF THE WIRE APPEARED TO BE INTACT. THE COATING FRAGMENTS WERE LEFT WITHIN THE PATIENT AT THE DISTAL END OF THE STRICTURE. THE PHYSICIAN DID NOT EXPRESS CONCERN OVER LEAVING THE COATING FRAGMENTS WITHIN THE PATIENT AND DETERMINED THAT THE FRAGMENTS WOULD PASS NATURALLY WITHOUT CAUSING HARM TO THE PATIENT. IN THE PHYSICIAN'S ASSESSMENT, THE GUIDEWIRE COATING DETACHED MOST LIKELY DUE TO THE TORTUOUS ANATOMY. THE PHYSICIAN THEN INSERTED THE OTHER END OF THE SAME HYDRA-JAGWIRE GUIDEWIRE INTO THE PATIENT TO COMPLETE THE PROCEDURE. THE WALLFLEX ENTERAL DUODENAL STENT WAS SUCCESSFULLY DEPLOYED ACROSS THE STRICTURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DURING THE STENT PLACEMENT PROCEDURE. ON (B)(6) 2011, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT HAD PASSED AWAY. THE DATE OF DEATH WAS NOT PROVIDED. IN THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF DEATH WAS A RESULT OF THE PANCREATIC CANCER AND PERITONITIS. IN ADDITION, A PERFORATION WAS DETECTED IN THE DUODENUM. IN THE PHYSICIAN'S ASSESSMENT, THE PERFORATION MAY HAVE BEEN A CAUSED BY THE HYDRA-JAGWIRE GUIDEWIRE OR THE DELIVERY CATHETER OF THE WALLFLEX STENT DURING THE INITIAL STENT PLACEMENT PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HYDRAJAGWIRE	STYLET FOR CATHETER, GASTRO-UROLOGY	EZB	BOSTON SCIENTIFIC - COSTA RICA	M00556071	14166092

Patients

Seq	Age	Sex	Outcome	Treatment
1	85 YR		Death	WALLFLEX