MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP COAXIAL UMBILICAL CABLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 203CX

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that black spots were observed on the coaxial umbilical cable in the unopened package.There was no patient involvement.

Manufacturer Narrative

Event summary: upon visual inspection of coaxial umbilical cable 203cx, results showed the coaxial umbilical cables was intact with no apparent issues.Coaxial cable 203cxc / 05734 failed the performance test due to foreign material inside the coax umbilical.In conclusion, the reported coax issue in packaging has been confirmed through testing.The coaxial umbilical cable failed the returned product inspection due to the foreign material inside the coax.If information is provided in the future, a supplemental report will be issued.

• Brand Name: COAXIAL UMBILICAL CABLE
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 7024010
• MDR Text Key: 92738019
• Report Number: 3002648230-2017-00607
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00643169950146
• UDI-Public: 00643169950146
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2019
• Device Model Number: 203CX
• Device Catalogue Number: 203CX
• Device Lot Number: 05734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/13/2017
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1