MAUDE Adverse Event Report: CAREFUSION, INC COSGROVE FLEX QCK-BEND 86MM FOGARTY-TYPE; CLAMP, VASCULAR

Catalog Number CV1186

Device Problems Material Rupture (1546); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Wire cable of the clamp ruptured during surgery.Possible serious or fatal consequences with open aorta or foreign bodies in the site.(b)(6) 2019 the customer reported, the affected device is not available for investigation because it has already been repaired during a revision.No serious injury was mentioned, only that a significant blood loss with fatal consequences would have been possible.No erroneous results, these could be prevented.Unknown course of treatment hanged or delayed as no information available.No exposure to blood/body fluid, was not mentioned.It was certainly necessary to intervene quickly with a replacement device as a medical intervention.No needle/probe stick.Yes safety issue.The device has been repaired since (b)(6) 2018, sent to biomed.

Event Description

Wire cable of the clamp ruptured during surgery.Possible serious or fatal consequences with open aorta or foreign bodies in the site.On (b)(6) 2019 the customer reported, the affected device is not available for investigation because it has already been repaired during a revision.No serious injury was mentioned, only that a significant blood loss with fatal consequences would have been possible.No erroneous results, these could be prevented.Unknown course of treatment hanged or delayed as no information available.No exposure to blood/body fluid, was not mentioned.It was certainly necessary to intervene quickly with a replacement device as a medical intervention.No needle/probe stick.Yes safety issue.The device has been repaired since december 2018, sent to biomed.

Manufacturer Narrative

1042074: b10: no sample and no representative picture of the device was received for investigation.As a result, it cannot be determined if all the components on the device were authentic v.Mueller components or if the device had been modified in any way prior to the complaint failure mode occurring.It was indicated that a date code of 11/18 was found on the device, however, per print cv1186 and the procedure the lot code for this device would be alpha-numeric, for example november 2018, would be k18.It is unclear what party has marked the device 11/18 but it may indicate the device has been altered.The complaint event description indicated that the wire cable of the clamp ruptured during surgery.Based on this description the cable that ruptured was item 99-900-071.Because a date code could not be provided, trending which may indicate an issue with a product lot cannot be identified.Because there is no visual or adequately detailed verbal description of the physical state of the cable, it cannot be determined where on the cable the rupture occurred or why the rupture occurred.Because neither an investigative sample nor a representative photo have been provided of the device involved in the complaint event, a root cause cannot be determined and the complaint failure mode is not verified.The customer indicated the device has already been repaired, as a result, any potential opportunities for evidence which may contribute to determining a root cause are limited.A potential follow up activity could be to return the ruptured cable if it was maintained by the repair facility, however, the functionality of components are dependent upon the components they are joined to, and not receiving the cable in its originally installed state, within the device involved in the complaint event, may limit the results that can still be obtained.The customer should be advised that the instructions for use for this device, ifu 36-2751, indicates a level of inspection and maintenance for the end-user to perform to prevent some damages and failure: inspect internal cable for kinking, fraying or any damage to the cable.If any of these conditions appear, do not use the device.Return devices to an authorized repair service center for repair or replacement.H3 other text : device not returned.

• Brand Name: COSGROVE FLEX QCK-BEND 86MM FOGARTY-TYPE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 8797666
• MDR Text Key: 151449494
• Report Number: 1923569-2019-00006
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CV1186
• Device Lot Number: 11/18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other