FDA Adverse Event Injury Summary report: N

MAVERICK2 BALLOON CATHETER

MDR report key: 1882018 · Received October 25, 2010

Report

Report Number: 2134265-2010-04788
Event Type: Injury
Date Received: October 25, 2010
Date of Event: September 24, 2010
Report Date: October 8, 2010
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LOX
PMA / PMN Number: P860019
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AGE AT TIME OF EVENT: 18 YEARS OR OLDER.(B)(4)DEVICE EVALUATED BY MANUFACTURER: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.(B)(4)

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE LESION CHARACTERISTICS ARE UNKNOWN. THE PHYSICIAN ATTEMPTED TO ADVANCE THE 30MM X 4MM MAVERICK2 BALLOON CATHETER ACROSS THE LESION, HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. AS THE MAVERICK2 BALLOON CATHETER WAS REMOVED FROM THE LESION, THE DISTAL 26CM OF THE DEVICE DETACHED AT THE LESION SITE. THE PHYSICIAN SUCCESSFULLY SNARED THE DETACHED SHAFT SEGMENT. NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MAVERICK2 BALLOON CATHETER	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	H7493892830400	12914842

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention