MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TORQVUE LP DELIVERY SYSTEM; DELIVERY SYSTEM TVLP 5F 80CM US

Model Number 9-TVLP5F90/080

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

An event that the delivery system was used subsequent to product expiration was reported.The reported product could not be confirmed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based solely on the device history record, the reported incident date of (b)(6) 2017 was after the use by/use before of 31 aug 2017.

Event Description

On 10 apr 2018, abbott was informed that a 5f amplatzer torqvue lp delivery system that was expired was used on a patient during a procedure on (b)(6) 2017.The delivery system was not expired when released to the customer and was noted to be expired post-procedure.The patient was discharged and there have been no adverse incidents reported.

Manufacturer Narrative

The reported event of use of the delivery system subsequent to its expiration date was confirmed.The device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including product sterilization prior to release.Based solely on the device history record, the reported incident date of (b)(6) 2017 was after the use by/use before of 31 aug 2017.As a result of this finding, abbott is performing further investigation.

• Brand Name: AMPLATZER TORQVUE LP DELIVERY SYSTEM
• Type of Device: DELIVERY SYSTEM TVLP 5F 80CM US
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7458414
• MDR Text Key: 106432961
• Report Number: 2135147-2018-00052
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K080757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 9-TVLP5F90/080
• Device Catalogue Number: 9-TVLP5F90/080
• Device Lot Number: 4821505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 10 YR
• Patient Weight: 35