MAUDE Adverse Event Report: INTEGRA YORK, PA INC. DEBAKEY MULTI CLAMP 60D 12; CARDIOVASCULAR CLAMPS 1

Catalog Number 320306

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that the 320306 debakey multi clamp 60d 12 was used during a surgical case on (b)(6) 2020 that resulted in a tear in the aortic tissue.Intervention was done.Additional information received on (b)(6) 2020 indicated that the (b)(6) year old male patient was taken to the operating room on (b)(6) 2020 at 1200 to repair a site of bleeding in the descending aorta which was complicated by further aortic injury requiring placement of an interposition graft (14mm).However, there was continued bleeding from all the suture sites therefore they were requested to place a covered stent in the aorta.Progress note from (b)(6) 2020 at 0250 stated that the patient underwent a chest washout on (b)(6) due to persistent high volume bleeding.He returned to the operating room (or) and underwent chest washout and was sent to operating room for chest exploration.In the operating room, patient was found to have a tear in the descending aorta at the site of aortic cannulation for transplant.A complex repair of the descending aorta was done which included attempted patch closure and eventually interposition graft of the descending aorta.The interposition graft was stented with a 16mm covered stent because of persistent bleeding at the suture sites.There was no known delay in procedure and patient outcome was unknown.

Event Description

N/a.

Manufacturer Narrative

The reported complaint could not be confirmed from evaluation of returned device.The product engraving does not match the reported product id 320306.Additional information received from competitor symmetry surgical confirmed device is not an integra device.The product was forwarded to symmetry surgical for evaluation.This complaint will be closed as a non-integra product.

• Brand Name: DEBAKEY MULTI CLAMP 60D 12
• Type of Device: CARDIOVASCULAR CLAMPS 1
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 10382070
• MDR Text Key: 202510171
• Report Number: 2523190-2020-00089
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K982365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR