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

Catalog Number	CQ7578
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no 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 a pta procedure of the lower arm, the balloon allegedly ruptured at 27atm during the initial inflation.It was further alleged that the pta balloon was retracted with some difficulty through the sheath and exchanged over the guidewire for another that was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.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 that has been reported for this corporate lot number to date.Visual inspection: the sample was returned.The balloon size for this product was printed on the balloon hub of the catheter and identified the returned sample as a 7 mm x 8 cm balloon.No anomalies noted to the device.Functional/performance evaluation: the patency of the guidewire lumen was tested using a 0.035¿ in-house guidewire and passed with no issues.The balloon was inserted through an in-house 6fr introducer sheath without issue.The inflation hub was then connected to an inflation device and an attempt was made to inflate the balloon with water.Upon inflation, water was observed exiting through the fibers, 1.2 cm from the distal tip.The balloon was deflated without issue.The balloon was able to be retracted through the in-house introducer sheath without issue.The balloon fibers were then stripped and the balloon was inflated again.A pinhole rupture was observed 0.6 cm from the distal tip.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 investigation was confirmed for a pinhole rupture.Additionally, the investigation was unconfirmed for sheath related retraction issues, as the device was able to insert and retract through an in-house sheath without issue.It is likely that the rupture contributed to the retraction issues.However, the definitive root cause for the rupture could not be determined based upon the available information.It was unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: warnings: 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.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.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 felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter, introducer sheath and guidewire (as necessary) as a single unit.Use of the conquest pta dilatation catheter: while maintaining negative pressure and the position of the guidewire, grasp the balloon catheter just outside the sheath and withdraw the deflated dilatation catheter over the wire through the introducer sheath.Use of a gentle counterclockwise motion may be used to help facilitate catheter removal through the introducer sheath.Additional mfr narrative: date received by mfr.Device evaluated by mfr?, (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 a pta procedure of the lower arm, the balloon allegedly ruptured at 27 atm during the initial inflation.It was further alleged that the pta balloon was retracted with some difficulty through the sheath and exchanged over the guidewire for another that was used to complete the procedure.There was no reported patient injury.

• Brand Name: CONQUEST 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: 6077606
• Report Number: 2020394-2016-01030
• Device Sequence Number: 817805
• Product Code: DQY
• UDI-Device Identifier: 00801741063015
• UDI-Public: (01)00801741063015(17)190131(10)REAN0744
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2016

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: 01/31/2019
• Device Catalogue Number: CQ7578
• Device Lot Number: REAN0744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2016
• Supplement Report FDA Received Date: 01/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1