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

Model Number 4FC12

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

The sheath 4fc12 with lot number 0009974359 was returned and analyzed.Visual inspection of the sheath showed the shaft was intact with no apparent issues.Air ingress was reproduced during aspiration of the sheath with a balloon test catheter introduced.The leak is most likely due to a tear in the hemostatic valve disc.In conclusion, the sheath failed the returned product inspection due to the air ingress during aspiration.If information is provided in the future, a supplemental report will be issued.

Event Description

The sheath subsequently tested out of specification per the manufacturer's investigation.

Manufacturer Narrative

The initial report sent for this product event was a duplicate report.This report is a duplicate of fda report number 3002648230-2020-00130.The analysis that was sent in this report will be submitted as additional information under the correct, initial report.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
• MDR Report Key: 10045133
• MDR Text Key: 195558880
• Report Number: 3002648230-2020-00269
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2021
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0009974359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1