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

Model Number 8780

Device Problem Retraction Problem (1536)

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

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

Analysis identified an anomaly to the catheter/guide wire.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care professional (hcp) via a device manufacturer representative regarding a patient receiving saline via an implantable infusion pump.It was reported that during initial catheter placement, the hcp was unable to withdraw the stylet from the catheter.Multiple attempts were made, but the stylet could not be removed.A new catheter set was utilized and the issue was resolved.There were no environmental, external or patient factors which may have led or contributed to the issue.No further complications were reported.2021-07-07 rp: document contained no new information.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12438396
• MDR Text Key: 270278465
• Report Number: 3004209178-2021-13469
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000051112
• UDI-Public: 00763000051112
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2023
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2021
• 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
• Patient Age: 53 YR
• Patient Weight: 122