ZERO TIP NITINOL STONE RETRIEVAL BASKET

Report

Report Number: 3005099803-2010-03661
Event Type: Injury
Date Received: August 31, 2010
Date of Event: July 2, 2010
Report Date: August 10, 2010
Manufacturer: BOSTON SCIENTIFIC - SPENCER
Product Code: FFL
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS OF THE RETURNED ZERO TIP NITINOL RETRIEVAL BASKET REVEALED THE DISTAL TIP OF THE WORKING LENGTH WAS DAMAGED AND FRAYED WHICH WOULD NOT ALLOW THE BASKET TO BE DEPLOYED. THERE WERE BENDS AND KINKS ALONG THE DRIVE WIRE, WHICH WOULD NOT ALLOW THE DRIVE WIRE TO MOVE FREELY. THE BASKET WAS PRESENT INSIDE THE OUTER SHEATH, THEREFORE, WAS NOT LEFT INSIDE THE PATIENT; THIS WOULD EXPLAIN WHY THE PHYSICIAN COULD NOT LOCATE THE PRESUMED DETACHED BASKET INSIDE THE PATIENT UNDER FLUOROSCOPY. ONE (1) LEG OF THE BASKET WAS BROKEN AT THE KNOT; THE BROKEN LEG DID EXHIBIT SIGNS OF STRESS AS IT WAS REDUCED IN OUTER DIAMETER AT THE BREAK LOCATION. BASED ON THE ANALYSIS OF THE RETURNED DEVICE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. THIS EVENT IS DETERMINED TO BE NOT A MEDWATCH REPORTABLE CONDITION BASED ON THE INVESTIGATION RESULTS REVEALING THE BASKET REMAINED ATTACHED TO THE DEVICE.

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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. AT THIS TIME WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO-TIP BASKET WAS USED DURING A RIGHT PERCUTANEOUS ULTRASONIC LITHOTRIPSY ON A FEMALE PATIENT (PATIENT IDENTIFIER AND WEIGHT NOT GIVEN). ACCORDING TO THE USER SUBMITTED MEDWATCH (B)(4), THE PHYSICIAN PLACED THE KIDNEY STONE BASKET THROUGH THE SCOPE TO RETRIEVE A STONE. AT THE TIME HE WAS ATTEMPTING TO WITHDRAW THE BASKET, IT BECAME "STUCK." HE WAS ABLE TO FINALLY PULL BACK ON THE GUIDE WIRE TO REMOVE THE BASKET THAT WAS ATTACHED TO THE END. WHEN HE PULLED THE WIRE OUT FROM THE TOP OF THE SCOPE, THE BASKET WAS MISSING AND IT APPEARED TO HAVE PULLED OFF THE END OF THE GUIDE WIRE. THE BASKET BROKE FROM THE END OF THE GUIDE WIRE INTEROPERATIVELY. HE USED ANOTHER BASKET TO REMOVE THE STONE. THEN WHEN HE WITHDREW, HE WITHDREW THE OPERATING SCOPE IN FULL AND NOTICED THAT THIS BASKET WAS ALSO LOOSE AT THE CONNECTION TO THE GUIDE WIRE. THIS WAS DONE EXTERNALLY TO THE PATIENT. THE FIRST BASKET COULD NOT BE LOCATED UNDER FLUORO EXAMINATION ALTHOUGH THE PHYSICIAN PERFORMED A THOROUGH EXAMINATION OF THE AREA. THE PHYSICIAN DOES NOT FEEL THAT IT WAS RETAINED, GIVEN HE COULD NOT VISUALIZE IT WITHIN THE SURGICAL ENVIRONMENT. PLEASE NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES. REF: 3005099803-2010-03681.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO-TIP BASKET WAS USED DURING A RIGHT PERCUTANEOUS ULTRASONIC LITHOTRIPSY ON A FEMALE PATIENT (PATIENT IDENTIFIER AND WEIGHT NOT GIVEN). ACCORDING TO THE USER SUBMITTED MEDWATCH (2100230000-2010-8004), THE PHYSICIAN PLACED THE KIDNEY STONE BASKET THROUGH THE SCOPE TO RETRIEVE A STONE. AT THE TIME HE WAS ATTEMPTING TO WITHDRAW THE BASKET, IT BECAME "STUCK." HE WAS ABLE TO FINALLY PULL BACK ON THE GUIDE WIRE TO REMOVE THE BASKET THAT WAS ATTACHED TO THE END. WHEN HE PULLED THE WIRE OUT FROM THE TOP OF THE SCOPE, THE BASKET WAS MISSING AND IT APPEARED TO HAVE PULLED OFF THE END OF THE GUIDE WIRE. THE BASKET BROKE FROM THE END OF THE GUIDE WIRE INTRAOPERATIVELY. HE USED ANOTHER BASKET TO REMOVE THE STONE. THEN WHEN HE WITHDREW, HE WITHDREW THE OPERATING SCOPE IN FULL AND NOTICED THAT THIS BASKET WAS ALSO LOOSE AT THE CONNECTION TO THE GUIDE WIRE. THIS WAS DONE EXTERNALLY TO THE PATIENT. THE FIRST BASKET COULD NOT BE LOCATED UNDER FLUORO EXAMINATION ALTHOUGH THE PHYSICIAN PERFORMED A THOROUGH EXAMINATION OF THE AREA. THE PHYSICIAN DOES NOT FEEL THAT IT WAS RETAINED, GIVEN HE COULD NOT VISUALIZE IT WITHIN THE SURGICAL ENVIRONMENT. PLEASE NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO-TIP BASKET WAS USED DURING A RIGHT PERCUTANEOUS ULTRASONIC LITHOTRIPSY ON A FEMALE PATIENT (PATIENT IDENTIFIER AND WEIGHT NOT GIVEN). ACCORDING TO THE USER SUBMITTED MEDWATCH (B)(4), THE PHYSICIAN PLACED THE KIDNEY STONE BASKET THROUGH THE SCOPE TO RETRIEVE A STONE. AT THE TIME HE WAS ATTEMPTING TO WITHDRAW THE BASKET, IT BECAME "STUCK." HE WAS ABLE TO FINALLY PULL BACK ON THE GUIDE WIRE TO REMOVE THE BASKET THAT WAS ATTACHED TO THE END. WHEN HE PULLED THE WIRE OUT FROM THE TOP OF THE SCOPE, THE BASKET WAS MISSING AND IT APPEARED TO HAVE PULLED OFF THE END OF THE GUIDE WIRE. THE BASKET BROKE FROM THE END OF THE GUIDE WIRE INTRAOPERATIVELY. HE USED ANOTHER BASKET TO REMOVE THE STONE. THEN WHEN HE WITHDREW, HE WITHDREW THE OPERATING SCOPE IN FULL AND NOTICED THAT THIS BASKET WAS ALSO LOOSE AT THE CONNECTION TO THE GUIDE WIRE. THIS WAS DONE EXTERNALLY TO THE PATIENT. THE FIRST BASKET COULD NOT BE LOCATED UNDER FLUORO EXAMINATION ALTHOUGH THE PHYSICIAN PERFORMED A THOROUGH EXAMINATION OF THE AREA. THE PHYSICIAN DOES NOT FEEL THAT IT WAS RETAINED, GIVEN HE COULD NOT VISUALIZE IT WITHIN THE SURGICAL ENVIRONMENT. PLEASE NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES. REF: 3005099803-2010-03681.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ZERO TIP NITINOL STONE RETRIEVAL BASKET	DISLODGER, STONE, BASKET, URETERAL, METAL	FFL	BOSTON SCIENTIFIC - SPENCER	M0063901050	13315977

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Other