MAUDE Adverse Event Report: CAREFUSION, INC FOGARTY HYDRAGRIP ANG JAW&SHANK 86MM CVD; CLAMP, VASCULAR

Model Number CV5050

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If further information becomes available a follow up medwatch will be submitted.

Event Description

The customer reported, inserts fell into the pleural space twice in a row on the same patient during use.The first insert fell into the pleural space and the insert was exchanged.However, the insert fell into the pleural space again.Both inserts were removed from the patient without difficulty.There was no silicone oil leakage or damages observed on the inserts.It was confirmed that the inserts were new, and they were attached to the jaw properly before use.Malfunction on clamp was also suspected.Therefore both inserts and used clamps were returned for evaluation.There were no patient complications reported.This record will capture the second event of falling into the patient's body.Additional information received on 23aug2017, the customer reported: date of the event: (b)(6) 2017, patient information was unknown, the insert was removed from the patient without difficulty, there were no patient complications reported, the insert fell into the pleural space and was removed from the patient without difficulty, the patient did not require any additional medical procedure such as an x-ray, unknown how the event was resolved, the product code of the insert: (b)(4), when the second insert fell into the patient and was removed it is unknown if the clamp was replaced, no audible snap was heard when placing the inserts onto the clamp receptacle, the cardiovascular surgery was completed as planned.

Manufacturer Narrative

Cfn-(b)(4).Device manufacture date: oct 2012.One (1) cv5050 fogarty hydragrip ang jaw&shank 86mm cvd was returned as the complaint sample.The etchings on the sample were noted to be legible, yet obscured by blemishes: the lot code was displayed as j12 (oct 2012), the sample was estimated to have been in use for about 5 years.The sample displayed a used appearance with signs of usage marks like scratches, nicks, dings, marring and surface scuff marks were noted all over and particularly towards the working end of the sample and the handle holding end.No signs of repair work, modifications and/or non-print or non-v.Mueller markings were noted on the sample.No other major defects, dents, breaking, cracking or any damages were noted.Functionally the sample was clamping and ratcheting normally, no issues were noted around box-lock area and the working end clamping jaws.The ratcheting teeth were noted to mesh normally and hold their locked position securely.Overall the sample appeared to be manufactured normally and maintained normally.The customer reported issues with the jaw inserts that mate onto the sample, the customer also noted returning the inserts for evaluations, and however no inserts were returned with the sample.The packaging was checked thoroughly and no inserts were found.It should be noted that the cv5050 and related fogarty clamps are manufactured at the v.Mueller facility.The jaw inserts that mate with the fogarty clamps are not manufactured by v.Mueller, recommended companies like edwards life sciences manufactures inserts that are made specifically to mate with v.Mueller fogarty clamps.Further investigations were only performed on the cv5050 sample and with the use of in-house sample soft86 jaw inserts by edwards life sciences.Per the complaint description the sample¿s jaws were investigation further.The jaw shaping was noted to be normal and the holes designated for the inserts were able to fit the sample soft86 (86mm) jaw inserts by edwards life sciences.The inserts went on with an audible snap and the fitment was noted to be secure, stable and flush with the surface of the clamp jaw.The clamp jaws with the inserts were activated multiple times and clamped down on tube shaped examples over several instances.No failure or detachment from the clamp jaws was noted.The jaws grasped onto various objects and the ratchet teeth securely locked on and closed on objects as thick as a pen/pencil.The inserts used were new from sealed packaging.It is possible that the issue is due to the type of jaw inserts that were used by customer during the time of failure.These inserts were not sent in as samples for evaluations.The cv5050 sample returned was noted to be in normal working condition.It is also possible that the end-user may not be affixing and securing the inserts correctly onto the clamp jaws.Furthermore, no other issues or signs of damages were observed on the sample.Device history record for cv5050 lot code j12 was reviewed.All work instructions were completed accordingly, and qa insert fit testing was performed.No deviations were noted related to the failure mode.Conclusion(s): based on the investigation of the returned sample and analysis: the failure modes reported in the complaint were not confirmed.Product was tested and investigated to function normally and mate with edwards jaw inserts.No other issues aside from the failure modes reported were identified.Root cause could not be determined due to failure mode not confirmed.It is possible that the issue is due to the type of jaw inserts that were used by customer during the time of failure.These inserts were not sent in as samples for evaluations.It is also possible that the end-user may not be affixing and securing the inserts correctly onto the clamp jaws and/or using the inserts multiple times.Els jaw inserts are for single use only.

• Brand Name: FOGARTY HYDRAGRIP ANG JAW&SHANK 86MM CVD
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 5 sunnen dr; st. louis MO 63143
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6827422
• MDR Text Key: 84125316
• Report Number: 1923569-2017-00051
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV5050
• Device Lot Number: J12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1