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

Model Number	CQF7564
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was 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 the pta balloon catheter was allegedly slow to deflate.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: 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 event reported to date for this lot number and failure mode.Visual inspection: the device was returned with the product label.The balloon size for this product was printed on the balloon hub of the catheter and identified the returned sample as a 6mm x 4cm balloon.No anomalies were noted to the device.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 connected to an inflation device, without the one way valve attached.The balloon was inflated to rated burst pressure (rbp) 40 atm with water and then deflated.The balloon took the appropriate shape upon inflation and was not asymmetrical in appearance.No issues were noted during deflation.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the device was returned for evaluation.No anomalies were noted to the returned sample.The returned sample was inflated and deflated without any issues.Therefore, the investigation was unconfirmed for deflation issues as the balloon functioned as intended during functional testing.The definitive root cause could not be determined based upon available information.It was unknown whether patient and/or procedural issues contributed to the event.It should be noted that per the reported event details, it was stated that the device was inflated with a syringe.The ifu (instructions for use) states that the use of a pressure monitoring device is recommended to prevent over pressurization.It was unknown whether the balloon/catheter was overpressurized or the use of a syringe contributed to the 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.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.
Event or Problem Description
It was reported that the pta balloon catheter was allegedly slow to deflate.There was no reported patient injury.

• 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: 6552940
• Report Number: 2020394-2017-00420
• Device Sequence Number: 954321
• Product Code: LIT
• UDI-Device Identifier: 00801741060441
• UDI-Public: (01)00801741060441(17)191130(10)REAY2424
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2017

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: 11/30/2019
• Device Model Number: CQF7564
• Device Catalogue Number: CQF7564
• Device Lot Number: REAY2424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 05/08/2017
• Supplement Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 98