• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Model Number CV5110
Device Problems Failure to Align (2522); Device Operates Differently Than Expected (2913)
Patient Problem Aortic Dissection (2491)
Event Date 01/16/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). On 28feb2017, writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. The device is not available for evaluation as it was discarded by the customer.
Event Description
Customer stated via email: during use in an aortic valve replacement and bypass surgery, the clamp jaws (case registered as (b)(4)) of the crossclamp (case registered as (b)(4)) did not confront each other correctly, causing an aortic dissection. Product number: unknown. I know from the description that it was a crossclamp, but no model number is available. Medical intervention was required and described as such: the patient was cooled down to 28ºc and the arterial brachio-cephalic trunk (tabac) was recannulated in order to perform an opened anastomosis and replace the descending aorta that was very fragile since it broke on clamp. The aortic cannula itself was removed, a circulatory collapse was done. When washing, a clear section of the media indicates the existence of clamp dissection. Then the aorta was resected and it was found that it is not possible to repair this lateral part on the aorta. A tube flow weave number 28 mm was implanted in circulatory collapse of 18 minutes by continuous overject of prolene 4-22 pressed on felt. This anastomosis was done at the bottom of the arterial brachio-cephalic trunk. There was no allegation of patient injury; however, the procedure was harder than expected. Unfortunately, the device is not available for evaluation as it was discarded by the customer. This is an international complaint from (b)(4). On (b)(6) 2017: the customer reported, i heard back from my counterpart in (b)(4). She was able to confirm that the clamp in question is model cv5110 and she confirmed that bd is the distributor. I provided her with the cfn# to reference when she contacts her bd contact. No further information available.
Manufacturer Narrative
(b)(4). One (1) cv5110 fogarty spring clip applicr forcep f/6mm was reported as the complaint device. The sample was not returned for evaluations, no pictures or further evidence were sent for review and no lot code was reported for the sample. Customer reported that the sample(s) were discarded at their facility and are not able to return them for further evaluations. The customer reported misalignment issues with the fogarty forceps during a surgical procedure. The complaint description describes possible patient injury during use of the sample. These forceps are mainly used to apply spring-clip type clamps on arteries/blood vessels for occluding, clamping, etc. Purposes. It was concluded from the reported description that the clamps cut/dissected the aorta artery that it was clamping down on. Customer did not identify exactly what type of spring-clip clamps were used and were not returned for review. It should be noted that fogarty forceps products are recommended to be used with fogarty/v. Mueller brand spring-clip clamp applicators, manufactured by edwards life sciences. These clips are usually a softer plastic-type material that come into direct contact with the arteries, blood vessels and human tissues. Fogarty forceps actual jaw tips are full stainless steel material and the surface is designed and manufactured to attach on to various disposable spring clip tips. It should be noted that these clips are technically handle-less clamps that are applied onto the vessel and the fogarty forcep (b)(4) can be un-attached off, leaving the spring loaded clips in place securing the blood vessel. The forceps parts are not to be used without attaching spring-clip clamps before surgical use. It is not known exactly how the fogarty forceps and clamps were used with the jaw inserts and it is not known how the products were clamped onto the artery. It is possible the wrong spring-clips were used or they were used more than once, also the clips may have been affixed on improperly and/or may have been clamped down improperly or with too much force. These possible causes cannot be confirmed without sample review. It should be noted that els spring-clips are one-time use only and the correct clip variation best suited for the procedure is recommended to be chosen due to the various designs and functionalities of the spring-clips. The els fogarty spring-clips are specifically designed to be used to provide a consistent degree of tension and the reduced force spring clip is designed to minimize vessel trauma while maintaining occlusion. Current reference manufacturing processes of the cv5110 were reviewed: finishing and assembly processes are clear and normal. The jaw parts are bent, belted and tumbled to provide a smooth finish and soft edges. There are also in-process checks and final checks by personnel to perform ratchet locking mechanism and ¿tap test¿ on 100% of the lot¿s pieces. Qa then inspects a sample size after manufacturing. The manufacturing processes were not suspected.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
5 sunnen dr
st. louis MO 63143
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
MDR Report Key6403848
MDR Text Key69908839
Report Number1923569-2017-00040
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCV5110
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/14/2017 Patient Sequence Number: 1