MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN HYBRID ADJUSTABLE SLITTER; STYLET, CATHETER

Model Number 6232ADJ

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Damaged during use.

Event Description

It was reported that during the implant of the left ventricular (lv) lead, during slitting of the delivery catheter there was a very thin plastic strip that was scratched off.The plastic strip is transparent so the physician and the nurse did not see that the strip wrapped around the lv lead connector.The plastic strip almost ripped out the lv lead as the nurse grabbed the delivery catheter to throw away after slitting.Slitting the outer delivery catheter with the same slitter was no issue.The remaining portion of the procedure was completed without any issues.Problem solving and further actions: no troubleshooting since the lv lead stayed at its positon after slitting procedure.It was also reported that it is unclear whether the slitter or the delivery catheter caused the thin transparent plastic strip.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN HYBRID ADJUSTABLE SLITTER
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5859307
• MDR Text Key: 52850688
• Report Number: 2182208-2016-01891
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 6232ADJ
• Device Catalogue Number: 6232ADJ
• Device Lot Number: 46105515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1