MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ACHIEVE ELECTRICAL CABLE

Model Number 990066

Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.This device was included in that field action.Based on the information received and without the return of the product, it could not determine this device performed as described in the field action.(b)(4).

Event Description

It was reported that prior to use, multiple mapping catheter electrical cables were received missing the outer box seal.It was noted that upon opening the catheters, there was a breached inner sterile package with cables that were labeled with tape.The cables were replaced and no patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the achieve electrical cable was returned and analyzed.The cable was received in its original packaging box with a missing tampering seal and an opened sterile package pouch.Visual inspection of the cable showed that the device was intact with no apparent issues.It was noted that some units were observed with a hand written tag and masking tape.No performance testing was conducted with these units.Also, the units were for qualification testing and were not intended clinical use.A product hold order (pho) and a field action was initiated.In conclusion, the reported issue of the compromised and opened packaging was confirmed through testing.The cable failed the inspection due to an open box and pouch.

Manufacturer Narrative

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

• Brand Name: ACHIEVE ELECTRICAL CABLE
• Type of Device: CABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5131793
• MDR Text Key: 27944711
• Report Number: 3002648230-2015-00333
• Device Sequence Number: 1
• Product Code: ISN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Followup,Followup,Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2017
• Device Model Number: 990066
• Device Catalogue Number: 990066
• Device Lot Number: U531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: CVG-16-Q2-12
• Patient Sequence Number: 1