MAUDE Adverse Event Report: MEDTRONIC, INC. ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	990063-015
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event summary: the patient data files showed at least forty-five injections were performed with catheter (b)(4), on the date of the event.The mapping catheter (b)(4), showed the shaft was kinked and broken 8.00 inches from the ecg connector, no ecg signal wires were broken inside the shaft, loop was kinked (misshaped), and pebax tube was ribbed.The mapping catheter failed the test due to shaft kink/broken and kink on the loop and pebax damage.The product analysis findings do not indicate a manufacturing related defect.In conclusion, the mapping catheter failed the returned product inspection due to a shaft kink, broken shaft, loop kink and pebax was ribbed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The mapping catheter was returned to the manufacturer, analyzed, and tested out of specification.

• Brand Name: ACHIEVE MAPPING CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 7985306
• Report Number: 9612164-2018-02841
• Device Sequence Number: 10804463
• Product Code: DRF
• UDI-Device Identifier: 00643169467378
• UDI-Public: 00643169467378
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K102588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2018

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: 04/10/2020
• Device Model Number: 990063-015
• Device Catalogue Number: 990063-015
• Device Lot Number: 215195240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1