MAUDE Adverse Event Report: MAQUET CV FUSION 6MM-40CM UNSUPP PERIPHERAL GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number VS015010460

Device Problem Delivered as Unsterile Product (1421)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There was no similar additional nonconformance which could be considered related to the reported event recorded in the lot history.Upon testing six samples from batch #(b)(4) of fusion bioline, (b)(6) has reported a non-conformance with sterilization and deemed the entire batch to be non-sterile.A review of the production batch records demonstrates that this batch of fusion product had been manufactured, packaged and shipped fully compliant with our quality assurance processes and in conformance with our sterilization specification.We are awaiting return of the shipment to the manufacturing facility in order to complete our investigation.A supplemental report will be filed upon completion of our investigation.

Event Description

Maquet (b)(4) received a report from the (b)(6) alleging upon routine random testing the device was deemed to be non-sterile.

Manufacturer Narrative

(b)(4).The inspection of the returned products from (b)(6) did not display any non-conformances, the third party laboratory results evidenced sterility, no further information was able to be obtained from the (b)(6) authority.Therefore the reported complaint for "disinfection or sterilization issue" was not confirmed.

Event Description

Maquet getinge group (b)(4) received a report from the (b)(6) alleging upon routine random testing the device was deemed to be non-sterile.

Manufacturer Narrative

(b)(4).The sample devices from the same lot were returned and processed through the nonconformance system (ncmr).The inspection of the returned products from (b)(4) did not display any non-conformances, the third party laboratory results evidenced sterility, no further information was able to be obtained from the (b)(4).Therefore, the reported complaint for "disinfection or sterilization issue" was not confirmed.

Event Description

Maquet (b)(4) received a report from (b)(6) alleging upon routine random testing the device was deemed to be non-sterile.

• Brand Name: FUSION 6MM-40CM UNSUPP PERIPHERAL GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5901091
• MDR Text Key: 53937978
• Report Number: 2242352-2016-00805
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K131778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: VS015010460
• Device Lot Number: 25114649
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1