MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number CQF5084

Device Problem Material Rupture (1546)

Patient Problem Intimal Dissection (1333)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

The device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported to date for this lot number and failure mode. Conclusion: the device was returned for evaluation. A visual inspection did not find any rupture related defects with the balloon. However, an inflation attempt was made and a longitudinal rupture was identified on the barrel of the balloon. Therefore, the investigation is confirmed for a longitudinal rupture. The definitive root cause for the identified rupture could not be determined based upon the available information. It is unknown if patient and/or procedural issues contributed to the reported event. Labeling review: the current ifu (instructions for use) states: warnings: do not exceed the rbp recommended for this device. Balloon rupture may occur if the rbp rating is exceeded. To prevent over pressurization, use of a pressure monitoring device is recommended. (b)(4).

Event Description

It was reported that during an angioplasty procedure in the proximal basilic vein, the pta balloon allegedly ruptured on the first inflation attempt. The pta balloon was exchanged over the guidewire for another that was used to complete the procedure. Reportedly, a small vessel dissection occurred post balloon rupture. Patient was reported to be asymptomatic post procedure.

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway.

Event Description

It was reported that during an angioplasty procedure in the proximal basilic vein, the pta balloon allegedly ruptured on the first inflation attempt. The pta balloon was exchanged over the guidewire for another that was used to complete the procedure. Reportedly, a small vessel dissection occurred post balloon rupture. Patient was reported to be asymptomatic post procedure.

• Brand Name: CONQUEST 40 PTA BALLOON DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6911881
• MDR Text Key: 249780850
• Report Number: 2020394-2017-01267
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2020
• Device Model Number: CQF5084
• Device Catalogue Number: CQF5084
• Device Lot Number: REBU0571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/03/2017 Patient Sequence Number: 1