MAUDE Adverse Event Report: MEDTRONIC, INC. PEELABLE PERCUTANEOUS LEAD INTRODUCERS (PLI); INTRODUCER, CATHETER

Model Number	6208-S1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during an implant procedure both ends of the lead introducer ruptured during cutting.The introducer was not used.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the introducer was returned and analyzed.The analysis indicated that the mechanical operation of the catheter shaft was kinked/buckled.Visual analysis of the lead indicated damage during use.The analyst noted that visual inspection found there was splitting problem on the introducer sheath.The begin of peeling the sheath appeared not on the score line due to a kink, and that caused another side of the handle to break and separated from the sheath.Another side of the handle was not received.The sheath body appeared peeling and cutting.According to the results, the analyst concluded that the sheath kinked causing the handle to break during peeling process.Then the physician tried their best by spiting and peeling the sheath to remove it from the lead.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PEELABLE PERCUTANEOUS LEAD INTRODUCERS (PLI)
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7655791
• Report Number: 2182208-2018-01217
• Device Sequence Number: 10803968
• Product Code: DYB
• UDI-Device Identifier: 00681490143172
• UDI-Public: 00681490143172
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K911236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2018

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: 11/08/2019
• Device Model Number: 6208-S1
• Device Catalogue Number: 6208-S1
• Device Lot Number: W4018237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 10/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR