MAUDE Adverse Event Report: CAREFUSION, INC FOGARTY HYDRAGRIP ANG JAW&SHANK 33MM; CLAMP, VASCULAR

Model Number CV5025

Device Problem Insufficient Information (3190)

Patient Problem Vascular Dissection (3160)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported, complaint (b)(4) vessel dissection occurred after the vessel was clamped with the fogarty clamp, including the soft33 inserts.It was reported that patient demographics are patient initials: (b)(6); (b)(6) year old male; (b)(6) kg, 188 cm.Surgery was kidney transplant.The clamp was used to clamp off the iliac artery, which dissected.A vascular surgeon was called to place a patch graft on the artery.No product return expected as devices were discarded at the facility.No pictures were taken.Although asked, no additional information was received.

Manufacturer Narrative

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

Event Description

Additional information received, 24feb2017: the end user reported, the patient was stable, which is a very generic term.The injury suffered by their iliac artery at the hands of the clamps was significant, but it was repaired, and the patient did well, despite having to prolong the case and remove and reflush the kidney.These are not small things.I have no idea if the soft33 inserts were used for the first time.I asked for "fogarty hydrogrip clamps", same as i have been doing at every transplant here over the past year, and same as i have been doing at three programs prior, since 2007, and i was handed some, which i used.I did not ask the brand name/model number of the clamps, nor did i carefully inspect them, because in 9-10 years, i have never had a reason to.This event was discussed in our qa/mm meeting, it was reported to our hospital administration, and it was reported to the patient and their family.It was not specifically answered if the user facility reported to regulatory authorities and no report number provided.

• Brand Name: FOGARTY HYDRAGRIP ANG JAW&SHANK 33MM
• 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: 6350006
• MDR Text Key: 68041623
• Report Number: 1923569-2017-00037
• 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: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CV5025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2017
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 42 YR
• Patient Weight: 116