PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5

Report

• Report Number: 9680794-2016-00172
• Event Type: Malfunction
• Date Received: October 6, 2016
• Date of Event: September 29, 2016
• Report Date: September 29, 2016
• Manufacturer: ARROW INTERNATIONAL INC.
• Product Code: DXE
• PMA / PMN Number: K011056
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Location: CA, US
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT IS FOR THE SECOND IN A SERIES OF TWO CONSECUTIVE PRODUCT PROBLEMS WITH THE SAME PATIENT. THE FIRST ISSUE HAS BEEN REPORTED UNDER MDR # 9680794-2016-00171.

Additional Manufacturer Narrative · 1

(B)(4) DEVICE EVALUATION: THE REPORTED COMPLAINT OF THE DISTAL BASKET TIP SEPARATED FROM THE BASKET WAS CONFIRMED. THE CUSTOMER RETURNED ONE 5 FR PTD CATHETER ASSEMBLY. THE ASSEMBLY WAS RETURNED WITH THE BASKET DEPLOYED FROM THE SHEATH AND PART OF TIP WAS MISSING FROM THE BASKET ASSEMBLY. MICROSCOPIC EXAMINATION REVEALED THAT THE BLACK TIP BROKE NEAR THE BASE OF THE DISTAL CONNECTOR AND APPROXIMATELY 2.5 MM OF TIP MATERIAL REMAINED ATTACHED TO THE CONNECTOR. THE BROKEN END OF THE REMAINING TIP MATERIAL APPEARED STRETCHED, FOLDED AND TWISTED OVER THE DISTAL END OF THE CONNECTOR. NO OTHER DEFECTS OR DAMAGE WERE OBSERVED WITH THE CATHETER OR THE BASKET. FUNCTIONAL TESTING WAS PERFORMED WITH THE RETURNED ASSEMBLY AND A LAB INVENTORY ROTATOR. THE BASKET WAS RETRACTED AND DEPLOYED AND ROTATED AS EXPECTED. THE IFU FOR THIS PRODUCT STATES UNDER GENERAL WARNINGS THAT THE PTD DEVICE IS NOT FOR USE IN STENTS. IT PROVIDES INSTRUCTIONS IN THE EVENT THE BLACK FLEXIBLE BASKET TIP "FOLDS OVER" ITSELF AND WHILE IN USE, STATES THAT THE EXPOSED PORTION OF THE CATHETER IS TO BE KEPT STRAIGHT AT ALL TIMES TO AID IN SUCCESSFUL BASKET DEPLOYMENT. IT WARNS THAT THE ROTATING BASKET IS TO BE WITHDRAWN IN THE DEPLOYED POSITION PRIOR TO REACHING THE SHEATH AT A RECOMMENDED RATE OF 1-2CM/SECOND WHEN SHARP RADII IS OTHER REMARKS: ENCOUNTERED AND THAT THE CATHETER IS NOT TO BE ADVANCED FORWARD DURING ACTIVATION. IT ALSO WARNS THAT POTENTIAL FATIGUE FAILURE OF THE PTD CABLE AND FRAGMENTATION BASKET MAY OCCUR WITH PROLONGED ACTIVATION OF THE PTD DEVICE. THE IFU ALSO PROVIDES VARIOUS WARNINGS AND PRECAUTIONS FOR THE USER TO REEVALUATE TREATMENT OR TO CONSIDER ALTERNATIVE TREATMENTS IF THERE IS A PRESENCE OF VENOUS OUTFLOW STENOSIS GREATER THAN 10CM LONG, UNTREATABLE CONDITIONS OR LARGE PSEUDOANEURYSM. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. THE MANUFACTURING PROCESS HAS NOT BEEN SHOWN AS A CAUSE AND THE SAMPLES HAVE MET THE TENSILE SPECIFICATION. THEREFORE, THE CAUSE OF THIS COMPLAINT IS UNDETERMINED. THE CUSTOMER REPORTED USING THE DEVICE THROUGH A STENT WHICH IS CONTRARY TO THE IFU. HOWEVER, AN INCREASE IN THE OCCURRENCE RATE FOR PTD TIP SEPARATION COMPLAINTS HAS RESULTED IN FURTHER INVESTIGATION OF THIS COMPLAINT ISSUE.

Description of Event or Problem · 1

IT WAS REPORTED A SECOND KIT WAS THEN OPENED AND USED FOR A DECLOT OF THE PATIENT'S FISTULA. THE PHYSICIAN WAS USING THIS THROUGH A STENT AS HE HAS DONE DOZENS OF TIMES OVER THE YEARS. AGAIN, THE TIP OF THE PTD DETACHED AND WAS LOST WITHIN THE PATIENT. AS A RESULT, A THIRD PTD WAS OPENED AND USED TO FINISH THE DECLOT PROCEDURE. THERE WAS A DELAY IN TREATMENT WITH NO PATIENT HARM AND NO PATIENT DEATH WAS REPORTED. FOLLOW UP INFORMATION STATES ONE PASS WAS MADE WITH THIS PTD BEFORE THE TIP FRACTURED. THE TIP WAS LEFT IN THE PATIENT. THE ENTIRE FISTULA WAS CLOTTED AND NO SHARP ANGELS WERE ENCOUNTERED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
658931	PERCUTANEOUS THROMBOLYTIC DEVICE SET: 5	PTD PRODUCTS	DXE	ARROW INTERNATIONAL INC.		13F16G0073

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Consequences Or Impact To Patient

Product problems · 1

• Material Separation

Source type · 2

• COMPANY REPRESENTATIVE
• HEALTH

Type of report · 2

• Followup
• Initial submission