MAUDE Adverse Event Report: COOK, INC. ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number PTA5-35-135-5-20.0

Device Problem Balloon rupture (1049)

Patient Problem Foreign body, removal of (2365)

Event Date 11/04/2014

Event Type  Injury  

Event Description

The physician was pre-dilating the lesion with the balloon when the balloon ruptured.A part of the balloon broke off and one long fragment remained in the body of the male patient.An intervention during the same procedure was performed to retrieve the balloon fragment.They got wire access through and from both access points in the groin, were able to pull the fragment out through the sheat over the wire.They successfully completed the originally intended ballooning and stenting.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event is still under investigation.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4332028
• MDR Text Key: 5256485
• Report Number: 1820334-2014-00627
• 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: Other
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Catalogue Number: PTA5-35-135-5-20.0
• Device Lot Number: 4906847
• Other Device ID Number: UDI#: (01)10827002355320(17)
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2014
• Device Age: 7 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2014
• 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