FDA Adverse Event Malfunction Summary report: N

NC SPRINTER RX BALLOON DILATATION CATHETER

MDR report key: 1881873 · Received October 8, 2010

Report

Report Number: 2953200-2010-01928
Event Type: Malfunction
Date Received: October 8, 2010
Date of Event: September 8, 2010
Report Date: September 8, 2010
Manufacturer: MEDTRONIC CARDIOVASCULAR GALWAY
Product Code: LOX
PMA / PMN Number: P9790017
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: OTHER (ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED BASED ON INFORMATION AVAILABLE). EVALUATION SUMMARY: THE BLUE TRANSITION SHAFT WAS STRETCHED AND MEASURED 23.1CM FROM THE PROXIMAL END OF THE HYPOTUBE BOND TO THE DETACHMENT SITE. THE TRANSITION SHAFT DETACHED IMMEDIATELY PROXIMAL TO THE GUIDE WIRE ENTRY PORT. THE GUIDE WIRE ENTRY PORT BOND WAS RETURNED STILL ATTACHED TO A SECTION OF DISTAL INNER AND OUTER SHAFTS. THE SECTION MEASURED 2.75MM IN LENGTH. THE REMAINING DISTAL SHAFT SECTION INCLUDING THE BALLOON AND DISTAL TIP WAS NOT RETURNED FOR EVALUATION.

Description of Event or Problem · 1

A 4.0MM DIAMETER X 12MM LENGTH NC SPRINTER RAPID EXCHANGE (RX) BALLOON DILATATION CATHETER WAS USED IN A PATIENT WITH NO ISSUE REPORTED. HOWEVER, IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL, THE DEVICE WAS PULLED OUT AND THE DISTAL PORTION OF THE CATHETER DETACHED IN THE TOUHY. IT WAS CONFIRMED THAT THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN COMMENTED THAT DUE TO THE LARGER BALLOON SIZE THAT THE BALLOON MAY HAVE "WINGED" AND GOT HUNG UP DURING WITHDRAWAL. THE PATIENT IS REPORTED TO BE FINE AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NC SPRINTER RX BALLOON DILATATION CATHETER		LOX	MEDTRONIC CARDIOVASCULAR GALWAY	NA	0001104424

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK