MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problems Nonstandard Device (1420); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient data files showed at least six injections were performed with catheter 2af283/31317 on the date of the event, system notice (b)(4) was received indicating that the safety system detected a compromised outer vacuum was triggered on application number six.Visual inspection of sheath, 4fc12/ 64100, showed the shaft was kinked and folded from the tip to 2.77 inches in proximal from the tip.In conclusion, the reported system notice (b)(4) was received indicating that ¿the safety system detected a compromised outer vacuum¿ issue has been confirmed through data analysis.The sheath failed the product inspection due to shaft kink.If information is provided in the future, a supplemental report will be issued.

Event Description

The sheath was returned to the manufacturer, analyzed, and tested out of specification.

Manufacturer Narrative

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

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7683393
• MDR Text Key: 114458210
• Report Number: 3002648230-2018-00481
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 02000012517520
• UDI-Public: 2000012517520
• Combination Product (y/n): N
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 64100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2018
• 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