MAUDE Adverse Event Report: CAREFUSION, INC COSGROVE FLEX QCK-BEND 61MM FOGARTY-TYPE; CLAMP, VASCULAR

Catalog Number CV1161

Device Problems Break (1069); Loose or Intermittent Connection (1371); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported a new complaint that happened while the device was clamping the aorta.The clamp gave out and the beads scattered into the patient.They had to stop the procedure to retrieve all the pieces but could only find 31 of the 32 beads and the spring.The cable broke at the jaw of the instrument and the spring was found in the chest.No the last bead was not found but the x-ray of the patient was negative.The instrument was being applied to the aorta by the surgeon.The scrub nurse had tested the instrument first prior to handing it up to the surgeon and it worked.The inserts are evergrip from edwards ref evergrip61.We are unable to provide patient information as per canadian privacy laws.There was no patient injury.The patient did require an intraoperative xray.The patient was stable medically after the event.The beads and spring fell into the patient's chest and were retrieved by the surgeon.The additional medical procedure required were the chest xray, which was negative.The device was removed from use and replaced with another and an incident report was filed.The valve replacement was completed as planned.

Manufacturer Narrative

951991: device mfr date: december 2008.One (1) cv1161 vm-cosgrove flex qck-bend 61mm fogarty was returned for evaluation as the complaint sample.The sample was returned broken apart and separated; noted was the clamp jaws separated from the body pieces, 31 loose beads and the jaw spring 10-300-360 were noted to be loose in the bag.Additionally, the metal lubrication tag was noted to remain on the ring handles of the sample.Etchings on the sample were slightly legible yet were noted to be faded, discolored worn and displayed signs of third party repair.The lot code was displayed as l08 (dec 2008), the sample has possibly been in use for about 10.5 years prior to complaint.Upon initial observations, the failure was verified and signs of obvious third party repair were observed.It was evident that the cable had broken at the joint closest to the clamping jaws, this caused the beads to release and come loose off of the cable wire, and this also caused the jaw spring to come loose.Thirty-two (32) beads are supposed to be on the sample as normally manufactured and etched with ¿32 beads¿ designation, the one missing bead was not noted anywhere on the sample or in the packaging.Upon further initial inspections the sample itself displayed a heavily used appearance all over the surfaces, which included heavy discoloration, surface wear, usage marks, scratches, nicks, and scuff marks.Most wear was noted towards the working end and the handle holding end.The sample was confirmed to be repaired/reworked by a third-party company, however no 3rd party marking/etching was noted.It was verified that the wound wires of the cable were noted to be unbroken and appeared to be different in design when compared to the stock oem (original equipment manufacturer) ocable used in 2008 lots.Furthermore the weld joints and the eye fittings at the cable ends were reworked in a non oem manner.It should be noted that the stock v.Mueller specified cable is made up of several thinner metallic wires that are woven and wound tightly to create one thicker cable (1 by 19).The complaint sample¿s cable was inspected at 2 times magnifications and compared to an in-house 99-900-070 cable sample: the complaint cable was noted to be significantly different in wound cable design, the threaded eye fitting (31-300-866) which goes in the handle was different in design, as in, it did not feature a swaged/crimped end, it featured more brazed and welded area.Visual inspections at the break failure area at 2 times magnifications, indicated that the break occurred 0.40 inches below the junction where the eye swage fitting (31-300-865) ends and where the cable begins.The break appeared to be a combination of ductile-shearing force, which left a burr/remnant of the cable wires in the eye fitting end.The remaining majority of the cable was noted to remain wound and very little fraying was noted at the end of the helical wound shape.Further evidence of the sample¿s cable wire being replaced by a 3rd party repair company was noted at the laser welded pin joints which holds the ends of the cable fittings.The laser weld of the holding pin was noted to be most likely broken and re-welded in a non-oem manner, indicating possible further improper third party repair.Finally, the failure of the separated cable end from the swage eye fitting was examined at magnifications to reveal that it was most likely different non-oem part assembled by 3rd party repair company without possibly swaging/crimping the fitting tight enough over the cable end, as a result the fitting did not withstand pulling forces and separated itself.The failure mode was severe enough to deem the sample as completely non-functional.No other breakpoints, corrosion, damages or signs of excessive forces were observed on the cable wire assembly.Conclusion(s): root cause ¿ based on the investigation of the returned sample and the reported failure/defect, the most probable root cause was determined to be improper third party repair.Overall assembly of the third party cable was determined to be inadequate, not indicative of a strong fitting and not up to the v.Mueller standards of strength.It should also be noted that the sample has been in use for over 10 years and displayed heavy signs of surface wear; additional factors such as any excessive forces improper care, lack of maintenance and/or lack of lubrication could have also contributed to the failure mode.

Event Description

The customer reported a new complaint that happened while the device was clamping the aorta.The clamp gave out and the beads scattered into the patient.They had to stop the procedure to retrieve all the pieces but could only find 31 of the 32 beads and the spring.The cable broke at the jaw of the instrument and the spring was found in the chest.No the last bead was not found but the x-ray of the patient was negative.The instrument was being applied to the aorta by the surgeon.The scrub nurse had tested the instrument first prior to handing it up to the surgeon and it worked.The inserts are evergrip from edwards ref evergrip61.We are unable to provide patient information as per canadian privacy laws.There was no patient injury.The patient did require an intraoperative xray.The patient was stable medically after the event.The beads and spring fell into the patient's chest and were retrieved by the surgeon.The additional medical procedure required were the chest xray, which was negative.The device was removed from use and replaced with another and an incident report was filed.The valve replacement was completed as planned.

• Brand Name: COSGROVE FLEX QCK-BEND 61MM FOGARTY-TYPE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 8627994
• MDR Text Key: 145736719
• Report Number: 1923569-2019-00004
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K991589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CV1161
• Device Lot Number: L08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 07/11/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention