MAUDE Adverse Event Report: COVIDIEN LLC CATHETER PASSER; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number	8591-38
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
Information was received from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a problem with an infusion catheter passer being used for spinal cord stimulation procedures.The hcp wanted to reported a product quality issue with the catheter passer.The hcp stated that lately anytime the physician tried to release the tab on the passer it was very hard to release and would then break off.The hcp was using the catheter passer to pass leads for spinal cord stimulation.The most recent issue occurred on (b)(6) 2020.(see manufacturer¿s report number 2182207-2020-00981 for the unknown passers.) additional information was received from the manufacturing representative (rep).It was reported the same issue occurred again on (b)(6) 2020.As the physician was releasing the tab from the tunneller a piece of the tab broke off.It was reported that none of these issues impacted the patient in any way.The catheter passer was disposed after every case so none were returned.

• Brand Name: CATHETER PASSER
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 10808347
• Report Number: 9612501-2020-01688
• Device Sequence Number: 17144197
• Product Code: LKK
• UDI-Device Identifier: 00763000031404
• UDI-Public: 00763000031404
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• 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
• Report Date (Section B): 11/09/2020

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: 09/04/2024
• Device Model Number: 8591-38
• Device Catalogue Number: 8591-38
• Device Lot Number: 0218470671
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1