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

Model Number	CQF5084
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6911881
• Report Number: 2020394-2017-01267
• Device Sequence Number: 125218
• Product Code: LIT
• UDI-Device Identifier: 00801741060267
• UDI-Public: (01)00801741060267
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

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
• Operator of Device: Health Professional
• 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
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 162