MAUDE Adverse Event Report: TELEFLEX MEDICAL DIAMOND-EDGE DISPOSABLE AORTIC PUNCH; INSTRUMENTS, SURGICAL, CARDIOV

Catalog Number DP-52K

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the arterial punch was applied twice.It would not release the second time.Then the handle came off.There was small damage to the artery but not critical according to the surgeon.

Event Description

It was reported that the arterial punch was applied twice.It would not release the second time.Then the handle came off.There was small damage to the artery but not critical according to the surgeon.

Manufacturer Narrative

Qn# (b)(4).A dhr review could not be conducted since the lot number was not provided.Sample was received without its original packing instead the sample was sent on a ziploc bag with a disinfection tag.Per visual inspection, blade and core are jammed due to lodged tissue are visible in the punch and also dried blood was spotted at the core and at the blade of the aortic punch.It was observed that the sample was received with the handle loose from the body.Body and handle were inspected, and signs of welding were observed inside the both plastic components with indicated welding process were performed.Also, the sample was received without the cross pin & spring.Dimensional inspection of core took place, dimensions are within specification.See attached inspection record and pictures.Blade wasn't measured because it was well assembled / welded into the body.It was preferred to keep the original assembly in purpose for further tests.It was not possible to perform functional testing to the sample due the missing components (pin & spring) and the loose assembly of the body & handle.Also, the core was found stuck inside the blade.As additional test, the sample was disassembled in order to be cleaned.Signs of lodged tissue are visible in the punch along the core and inside the blade.In order to try to perform functional testing, production samples of components pin # & spring were used to assemble the sample with the other original components.It was not possible to weld the assembly of the original body & handle again because it was not allowed to introduce used components inside the clean assembly room.Even that, the rest of the components was assembled.Sample was tested manually, and it works fine.Core returns without obstructions.Also, it was possible to performed cuts to a pork aorta to review the functionality of the unit.No issues were found during testing.It is not possible to establish a corrective action since the sample was received with missing components and a body loose from the body.However, once the sample was assembled again by using production samples components; it was possible to test manually, and it works fine.Core returns without obstructions.Based on this and according attached product ifu (steps # 3 & 4), a possible improper cleaning technique could be determined as the probable cause since caught tissues were observed in the devices and no issues were found after cleaning them.Based on the visual inspection of the sample received, the complaint is confirmed.Although the condition observed on the sample provided, there is no sufficient evidence to assure that this issue was originated during the manufacturing assembly.The lodged tissue observed in the punch could be caused due a possible improper cleaning technique.Sample was cleaned, assembled and tested again with no issues related to the reported issue.However, the personnel of the assembly line will be notified for awareness.

• Brand Name: DIAMOND-EDGE DISPOSABLE AORTIC PUNCH
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOV
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8116339
• MDR Text Key: 129056094
• Report Number: 3004365956-2018-00354
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/22/2018

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 Catalogue Number: DP-52K
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Manufacturer Received: 11/22/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1