MAUDE Adverse Event Report: COOK, INC. ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

Catalog Number PTA5-35-80-10-2.0

Device Problem Balloon rupture (1049)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/21/2014

Event Type  Injury  

Event Description

During a thrombectomy fistulogram on a (b)(6) male patient, hand inflation was used to inflate all of the balloons in this procedure.The first balloon went through the sheath one time and was used successfully once.They attempted to use the first balloon again and it would not reenter the sheath.They attempted to rewrap the balloon but it would not go into the sheath.They then opened a second balloon.The second balloon went through the sheath one time and was used successfully once.They attempted to use the second balloon again and it would not reenter the sheath.They attempted to rewrap the balloon but it would not go into the sheath.They then opened a third balloon.This balloon ruptured during its second inflation.Balloon fragments remained inside the patient's right axillary vein.A stent was used to tack the balloon fragments to the vessel wall so that the fragments don't cause harm to the patient.

Manufacturer Narrative

(b)(4).

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 8122392235
• MDR Report Key: 3894097
• MDR Text Key: 4539468
• Report Number: 1820334-2014-00252
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: PTA5-35-80-10-2.0
• Device Lot Number: 4783386
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/21/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 77