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

Model Number	CQF7588
Medical Device Problem Codes	Deflation Problem (1149); Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
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 return of the device is pending.The investigation is currently under way.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 after the first inflation in the cephalic arch, the pta balloon allegedly would not deflate.The health care provider pulled the catheter up into the shoulder region and used a needle stick through the skin to deflate the balloon.It was further reported that during retraction through the sheath, the balloon catheter allegedly became lodged.The catheter and sheath were removed together as a single unit without further incident.Reportedly, another balloon catheter and sheath were used to complete the procedure.The patient was reported as asymptomatic post procedure.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary: the investigation is inconclusive, as the sample was not returned for evaluation.The definitive root cause for the reported issues 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.- 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 after the first inflation in the cephalic arch, the pta balloon allegedly would not deflate.The health care provider pulled the catheter up into the shoulder region and used a needle stick through the skin to deflate the balloon.It was further reported that during retraction through the sheath, the balloon catheter allegedly became lodged.The catheter and sheath were removed together as a single unit without further incident.Reportedly, another balloon catheter and sheath were used to complete the procedure.The patient was reported as asymptomatic post procedure.

• 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: 7149036
• Report Number: 2020394-2017-01812
• Device Sequence Number: 11040191
• Product Code: DQY
• UDI-Device Identifier: 00801741060571
• UDI-Public: (01)00801741060571
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 01/30/2018

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 Model Number: CQF7588
• Device Catalogue Number: CQF7588
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 01/30/2018
• 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: 60 YR
• Patient Weight: 75