MAUDE Adverse Event Report: IBC (INTERNATIONAL BIOPHYSICS CORP) V MUELLER VASCULAR LOOPS MINI RED STRL; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number CH115

Device Problems Stretched (1601); Material Integrity Problem (2978)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) on 10may2016 customer advocacy sent the customer an email acknowledging receipt of the complaint, providing the complaint number, and inquiring if additional information may be available.Confirmation was also requested from the customer that there was no patient impact associated with reported issue.On 23may2016 the complaint was closed, and on 31may2016 the customer sent additional information.Device was evaluated by the manufacturer and it could not confirm the reported issue.Based upon the testing performed, all products performed as expected there were no defects noted.No root cause could be established.

Event Description

Sales rep reported via email the product is stretching like rubber bands.On 31may2016 additional information: was the product received in this condition? yes.If not, what was the product being used for when it was observed that product is stretching like rubber bands? these are used on carotids and endovascular stent cases.Please confirm whether or not there was any patient impact.Yes, numerous doctors had trouble controlling the bleeding and had to use clamps instead.Do you have the lot#? were sent in but all product on our shelves are not safe for use.The new liga-loops appear to be made from plastic material with minimal elasticity.The plastic just stretches and does not constrict to control the bleeding.Both cases the surgeons had blood baths during the procedures which ultimately affect the patients.

• Brand Name: V MUELLER VASCULAR LOOPS MINI RED STRL
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): IBC (INTERNATIONAL BIOPHYSICS CORP); 2101 east st. elmo road; austin TX 78744
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628063
• MDR Report Key: 5709738
• MDR Text Key: 46918639
• Report Number: 1423507-2016-00060
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2016

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 Model Number: CH115
• Device Lot Number: 111115-3864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other