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

Model Number 4FC12

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the 4fc12 sheath with lot 0010663031 was returned and analyzed. Visual inspection prior to disassembly and functional testing was performed on the shaft, handle, and dilator. No anomalies were identified. The handle has no cosmetic issue and side tube is connected properly to the handle. The shaft had multiple kinks approximately 2 inches from tip. The steering mechanism of the sheath was tested and no anomalies were noted in the handle segment, it is plausible that due to the possible kink the user might have reported the steering issue as the shaft would not deflect properly. In conclusion, the sheath failed the returned product inspection due to a shaft kink. If information is provided in the future, a supplemental report will be issued.

Event Description

After a completed case, the sheath subsequently tested out of specification per the manufacturers investigation.

• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14318021
• MDR Text Key: 292513723
• Report Number: 3002648230-2022-00197
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: MG
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/06/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010663031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial