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

Model Number	C304-HIS
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2019
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 implant, the physician was unable to slit the catheter completely and got stuck near the distal tip.The catheter was slit the rest of the way with scissors and a copper piece was seen at the distal tip where the physician got stuck during slitting.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the delivery catheter was returned and analyzed.Analysis indicated that the mechanical operation of the catheter slitting showed a spiral slit.The catheter did not peel along the score lines.The mechanical operation of the catheter was damaged.The mechanical operation of the catheter shaft was kinked.Visual analysis of the lead indicated damage during use.The analyst noted that visual inspection was found slit was not on score line causing spiral slit and the deflectable wire came out of the catheter shaft and broke near to the distal end.The copper ring was also damaged.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: 9194477
• Report Number: 9612164-2019-04372
• Device Sequence Number: 2600131
• Product Code: DQY
• UDI-Device Identifier: 00763000147006
• UDI-Public: 00763000147006
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K183493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: 05/21/2021
• Device Model Number: C304-HIS
• Device Catalogue Number: C304-HIS
• Device Lot Number: 0009751459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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