MAUDE Adverse Event Report: MEDTRONIC IRELAND SELECTSITE; CATHETER, PERCUTANEOUS

Model Number	C304L6906
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
5554-45, lead implanted (b)(6) 2003.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the right ventricular (rv) lead replacement, the delivery catheter was difficult to slit and had fibrous strands.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full delivery catheter was returned in segments, and analyzed.Analysis indicated that the mechanical operation of the catheter peeling/slitting/splitting showed a spiral slit.The mechanical operation of the catheter was damaged.The mechanical operation of the catheter shaft was kinked/buckled.Visual analysis of the lead indicated damage during use.The analyst noted that the catheter was returned with severe damage.Visual inspection found that there was not a nice straight slit cut at the beginning.The shaft was damaged during slitting procedure: spiral slit visible on the shaft.The inner wire was exposed from the shaft.Outer shaft was visibly kinked.The inner wire coating torn and appeared fibrous.The gold band was damaged and inner wire was separated from the gold band.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SELECTSITE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7414815
• Report Number: 9612164-2018-00698
• Device Sequence Number: 13692981
• Product Code: DQY
• UDI-Device Identifier: 00613994729774
• UDI-Public: 00613994729774
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2019
• Device Model Number: C304L6906
• Device Catalogue Number: C304L6906
• Device Lot Number: 0008820970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR