MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ASCENDA; CATHETER, INFUSION

Model Number	8780
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
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 professional (hcp) regarding a catheter used with an implanted infusion pump.Per the hcp, the catheter was not used as it broke during the procedure and it was discarded in the or (operating room).The hcp could not remember the date of the event or many details, but noted that they didn't think there was a defect with the catheter.The hcp thought it was the patient's anatomy as the patient was a child.The manufacturer representative present at the case further noted that the physician damaged both catheters by bending them before implanting them in the patient.The account reportedly felt it was user error so the catheter was not returned.The device was never implanted, so no additional tunneling was required.There was no impact to the patient and the device wasn't used further.It was specified that the implant was successful.No further complications were reported or anticipated.

• Brand Name: ASCENDA
• Common Device Name: CATHETER, INFUSION
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7557247
• Report Number: 3007566237-2018-01643
• Device Sequence Number: 13927790
• Product Code: JCY
• UDI-Device Identifier: 00643169783027
• UDI-Public: 00643169783027
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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: 03/20/2020
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1