MAUDE Adverse Event Report: CAREFUSION, INC COSGROVE FLEX CLAMP 61MM FOGARTY JAW; CLAMP, VASCULAR

Catalog Number CV1061

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If further information becomes available a follow up medwatch will be submitted.Device not returned.

Event Description

During operation when the jaws grasped the aorta, the user tried to unlock the jaws but the ratchet didn¿t move for about 10 minutes.Procedure completed as planned.No sample to return.Unknown patient information, no patient injury or medical intervention, the event was resolved by the user in an unspecified manner by himself.The procedure being performed was an abdominal aortic aneurysm artificial blood vessel replacement surgery.( per jss distributor: when we received the reported device, it had already been cleaned and we were not able to reproduce the reported nature.-according to the corrosion, we imagined any rust or contamination attached to rust or any blood residue were stuck in the spring part of the jaw box which made the jaw open unavailable.-we explained to the user and returned the reported device to the user.).

Event Description

During operation when the jaws grasped the aorta, the user tried to unlock the jaws but the ratchet didn¿t move for about 10 minutes.Procedure completed as planned.No sample to return.Unknown patient information, no patient injury or medical intervention, the event was resolved by the user in an unspecified manner by himself.The procedure being performed was an abdominal aortic aneurysm artificial blood vessel replacement surgery.( per (b)(6) distributor: when we received the reported device, it had already been cleaned and we were not able to reproduce the reported nature.According to the corrosion, we imagined any rust or contamination attached to rust or any blood residue were stuck in the spring part of the jaw box which made the jaw open unavailable.We explained to the user and returned the reported device to the user.).

Manufacturer Narrative

(b)(4).Device history records for cv1061 from lot code j16 were reviewed: all work instructions and documentation were completed accordingly.Any reported deviations or non-conformances were handled appropriately.Quality assurance testing were performed, all inspections passed.One (1) cv1061 vm-cosgrove flex clamp 61mm fogarty jaw was reported as the complaint sample.The customer provided pictures were sent of the failed sample with etching side facing up and visible in the picture.The etchings on the sample picture were noted to be legible and v.Mueller original, the lot code was observed as j16 ((b)(6) 2016) on the handle body shaft.The sample appeared to be used.Initial visual verification of the pictures could not verify any component failure.The close-up zoomed pictures were of the jaw ends and possibly the underside of the lower jaw.Complete visual verification could not be confirmed.Further verifications of any other issues, damages and/or end user modifications could not be completed.The exact occurrence of failure is unknown, unless sample is verified functionally.The lot number was inadvertently reported incorrectly previously.

• Brand Name: COSGROVE FLEX CLAMP 61MM FOGARTY JAW
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 7753352
• MDR Text Key: 116866483
• Report Number: 1923569-2018-00018
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K974769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CV1061
• Device Lot Number: J16
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other