MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ASCENDA; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8780

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

Event Description

Information was received from foreign healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient with an implantable pump.On (b)(6) 2021, it was reported that, during the surgical procedure to position the catheter, the surgeon could not manage to withdraw the guide wire inside the catheter. the catheter was in csf withthe metallic guide wire inside it. no environmental/external/patient factors that might have led or contributed to the issue were noted.The surgeon tried several times to withdraw the catheter, but after multiple attempts, a new catheter was used instead.Everything went "fine" with the new device.It was confirmed that the catheter with the guidewire was not implanted.The issue was considered resolved at the time of the event.The patient's status was listed as "alive - no injury".

Manufacturer Narrative

The catheter was returned and analysis found an anomaly to the catheter/guidewire.It was clarified that damage was observed in the catheter body and/or guidewire during the implant procedure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ASCENDA
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13712038
• MDR Text Key: 295359914
• Report Number: 3004209178-2022-03034
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Device Lot Number: 0222586743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• 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