MUSTANG BALLOON DILATATION CATHETER

Report

Report Number: 2134265-2011-03068
Event Type: Injury
Date Received: July 28, 2011
Date of Event: July 5, 2011
Report Date: July 5, 2011
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: LIT
PMA / PMN Number: K103751
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED IN TWO PIECES. A PART OF THE TIP, STRETCHED TO A LENGTH OF 120MM WAS RETURNED DETACHED FROM THE DEVICE. THE DISTAL END OF THE BALLOON, BALLOON TIP AND MARKERBANDS WERE DETACHED AND NOT RETURNED WITH THE DEVICE. A SECTION OF THE BALLOON (20MM IN LENGTH) REMAINED BONDED TO THE PROXIMAL BOND. THE BALLOON HAD BEEN TORN CIRCUMFERENTIALLY. NO FURTHER DAMAGE TO THE DEVICE WAS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER RELATED AS THE PHYSICIAN INFLATED THE DEVICE TO 24ATMS WHICH IS ABOVE ITS RBP. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A CORONARY ANGIOPLASTY PROCEDURE A VESSEL PERFORATION AND BALLOON RUPTURE AND DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY STENOSED VEIN GRAFT ANASTAMOSIS. AN 8.0X40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED TO 24ATMS. THE BALLOON RUPTURED AFTER THE THIRD INFLATION, CAUSING A VESSEL PERFORATION. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE, WITHDRAWAL RESISTANCE OCCURRED AND WHEN THE DEVICE WAS REMOVED FROM THE PATIENT IT WAS NOTED THE BALLOON WAS TORN CIRCUMFERENTIALLY AND TWO-THIRDS OF IT WAS MISSING FROM THE CATHETER. A NON BSC CATHETER WAS ADVANCED TO THE LESION TO IDENTIFY WHERE THE BALLOON MATERIAL WAS AND IT WAS FOUND ON THE TIP OF THE NON BSC CATHETER THAT WAS JUST ADVANCED. THE BALLOON MATERIAL THEN WORKED ITS WAY INTO THE PULMONARY ARTERY. THE BALLOON MATERIAL WAS LEFT IN THE PULMONARY ARTERY AS THE PATIENT WAS VERY SICK AND THE PHYSICIAN DID NOT WANT TO FURTHER THE PROCEDURE BY ATTEMPTING TO REMOVE IT. AN UNKNOWN COVERED STENT WAS DEPLOYED IN THE LESION TO SUCCESSFULLY COVER THE PERFORATION AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL LATER THAT DAY IN STABLE CONDITION.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A CORONARY ANGIOPLASTY PROCEDURE A VESSEL PERFORATION AND BALLOON RUPTURE AND DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY STENOSED VEIN GRAFT ANASTAMOSIS. AN 8.0X40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED TO 24ATMS. THE BALLOON RUPTURED AFTER THE THIRD INFLATION, CAUSING A VESSEL PERFORATION. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE, WITHDRAWAL RESISTANCE OCCURRED AND WHEN THE DEVICE WAS REMOVED FROM THE PATIENT IT WAS NOTED THE BALLOON WAS TORN CIRCUMFERENTIALLY AND TWO-THIRDS OF IT WAS MISSING FROM THE CATHETER. A NON BSC CATHETER WAS ADVANCED TO THE LESION TO IDENTIFY WHERE THE BALLOON MATERIAL WAS AND IT WAS FOUND ON THE TIP OF THE NON BSC CATHETER THAT WAS JUST ADVANCED. THE BALLOON MATERIAL THEN WORKED ITS WAY INTO THE PULMONARY ARTERY. THE BALLOON MATERIAL WAS LEFT IN THE PULMONARY ARTERY AS THE PATIENT WAS VERY SICK AND THE PHYSICIAN DID NOT WANT TO FURTHER THE PROCEDURE BY ATTEMPTING TO REMOVE IT. AN UNKNOWN COVERED STENT WAS DEPLOYED IN THE LESION TO SUCCESSFULLY COVER THE PERFORATION AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL LATER THAT DAY IN STABLE CONDITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MUSTANG BALLOON DILATATION CATHETER	CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL	LIT	BOSTON SCIENTIFIC - GALWAY	H74939171080470	14319846

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Required Intervention