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

Catalog Number	CQF7564
Medical Device Problem Codes	Material Frayed (1262); Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
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.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that during an angioplasty procedure at the arterial anastomosis, the pta balloon allegedly ruptured after the second inflation attempt using a one cc syringe.Reportedly the balloon got stuck in the sheath during retraction.The procedure was completed with the original balloon because the rupture occurred after the stenosis was effaced.There was no reported patient injury.
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.Visual/microscopic inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as an 6 mm x 4 cm balloon.The distal end of the balloon was examined under microscopic magnification and was observed to be bunched and protruding out the distal end of the introducer sheath.Fiber disturbance noted 3.0 cm from the distal tip.No other anomalies were noted to the device at this time.The introducer sheath examined under microscopic magnification.The introducer sheath was bunched and the distal tip of the introducer sheath was observed to be flared, indicating retraction issues.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.035¿ guidewire, and it passed without issue.The balloon was unable to be retracted through the introducer sheath.The balloon was able to be advanced forward through the introducer sheath with slight resistance.The inflation hub was connected to an in-house inflation device and an attempt was made to inflate the balloon with water.The balloon was unable to be inflated, as water leaked out of the fibers of the balloon 3.0 cm from the distal tip.The balloon fibers were then stripped and a longitudinal rupture was found 3.0 cm from the distal tip, extending 1.0 cm.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was returned within the customer's 6fr sheath.Based on the condition of the returned sample, the investigation is confirmed for a longitudinal rupture, sheath related retraction issues and frayed material.The balloon rupture likely contributed to the retraction issues and frayed material.It is unclear if patient and/or procedural issues contributed to the event.However, based upon the available information the definitive root cause is unknown.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.- when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation.Precautions: - if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon.- if resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit.(b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that during an angioplasty procedure at the arterial anastomosis, the pta balloon allegedly ruptured after the second inflation attempt using a one cc syringe.Reportedly the balloon got stuck in the sheath during retraction.The procedure was completed with the original balloon because the rupture occurred after the stenosis was effaced.There was no reported patient injury.

• Brand Name: CONQUEST 40 PTA BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6370523
• Report Number: 2020394-2017-00133
• Device Sequence Number: 442913
• Product Code: DQY
• UDI-Device Identifier: 00801741060441
• UDI-Public: (01)00801741060441(17)190728(10)REAV0156
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2019
• Device Catalogue Number: CQF7564
• Device Lot Number: REAV0156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 04/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 77