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

Model Number 8591-38

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10808347
• MDR Text Key: 217312065
• Report Number: 9612501-2020-01688
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000031404
• UDI-Public: 00763000031404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 8591-38
• Device Catalogue Number: 8591-38
• Device Lot Number: 0218470671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/09/2020
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1