FDA Adverse Event Malfunction Summary report: N

IMPULSE GUIDE CATHETER

MDR report key: 3981081 · Received August 5, 2014

Report

Report Number: 2134265-2014-04915
Event Type: Malfunction
Date Received: August 5, 2014
Report Date: July 11, 2014
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: DQO
PMA / PMN Number: K992142
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF THE PROXIMAL 70MM OF AN IMPULSE DEVICE. THERE WAS DRIED CONTRAST ON THE HUB OF THE DEVICE. THE DISTAL END OF THE RETURNED DEVICE APPEARED TO HAVE BEEN CUT IN THREE LOCATIONS, WHICH IS CONSISTENT WITH THE REPORTED INFORMATION. THE PACKAGING WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PACKING AND DEVICE HAD FOREIGN MATTER. UPON UNPACKING AN IMPULSE GUIDE CATHETER IT WAS NOTED THAT THE INSIDE OF THE PACKAGING AND ON THE HUB WINGS THERE APPEARED TO BE DIRT OR DUST. THERE WAS NO PATIENT INVOLVED AND NO PATIENT COMPLICATIONS WERE REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PACKING AND DEVICE HAD FOREIGN MATTER. UPON UNPACKING AN IMPULSE GUIDE CATHETER, IT WAS NOTED THAT THE INSIDE OF THE PACKAGING AND ON THE HUB WINGS THERE APPEARED TO BE DIRT OR DUST. THERE WAS NO PATIENT INVOLVED AND NO PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
457402	IMPULSE GUIDE CATHETER	CATHETER, INTRAVASCULAR, DIAGNOSTIC	DQO	BOSTON SCIENTIFIC - MAPLE GROVE	H74916391402	0050798086

Patients

Seq	Age	Sex	Outcome	Treatment
1