MAUDE Adverse Event Report: INTERNATIONAL BIOPHYSICS CORPORATION VASCULAR LOOP; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number CH115

Device Problem Stretched (1601)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

On may 23, 2016 the original complaint was closed after investigation.The complaint was re-opened when additional information was received by the customer on 06/09/2016.The device was returned for evaluation, and based on the results of the testing performed all products operated within specification and there were no defects noted.No root cause could be established.

Event Description

Reported by customer: "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: VASCULAR LOOP
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): INTERNATIONAL BIOPHYSICS CORPORATION; 2101 e. st. elmo road; suite 275; austin TX 78744
• Manufacturer (Section G): INTERNATIONAL BIOPHYSICS CORPORATION; 2101 e. st. elmo road; suite 275; austin TX 78744
• Manufacturer Contact: geoffrey marcek ; 2101 e. st. elmo road; suite 275; austin, TX 78744 ; 5128140046
• MDR Report Key: 5728091
• MDR Text Key: 47493554
• Report Number: 1645362-2016-00005
• 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: 06/15/2016

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 Expiration Date: 11/11/2019
• Device Model Number: CH115
• Device Catalogue Number: CH115
• Device Lot Number: 111115-3864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other