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

Model Number	CQ7554
Medical Device Problem Codes	Burst Container or Vessel (1074); Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2018
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 return of the device is pending.The results of the anticipated device evaluation will be provided upon completion of the event investigation.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 in an upper arm dialysis fistula, the pta balloon allegedly ruptured and was difficult to retract through the sheath, which led to a balloon detachment.The pta balloon and sheath were removed together as one unit.Another pta balloon was used to successfully complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
The device history records have been reviewed and 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.The device was returned for evaluation.A visual inspection found a complete burst in the catheter shaft, confirming the investigation for a burst.However, as the balloon was unable to be inflated fully due to the shaft burst, the investigation is inconclusive for the reported sheath-related retraction issue and balloon rupture.The investigation is unconfirmed for the reported detachment as the balloon was returned fully attached to the catheter shaft, and as no other detachments were noted.It is possible that the user perceived the identified catheter shaft burst as the reported balloon rupture, as both failures could contribute to a sheath-related retraction issue.However, the definitive root cause for the reported or identified issues could not be determined based on the available information.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(4).
Event or Problem Description
It was reported that during an angioplasty in an upper arm dialysis fistula, the pta balloon allegedly ruptured and was difficult to retract through the sheath, which led to a balloon detachment.The pta balloon and sheath were removed together as one unit.Another pta balloon was used to successfully complete the procedure.There was no reported patient injury.

• Brand Name: CONQUEST PTA 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: 7636304
• Report Number: 2020394-2018-00977
• Device Sequence Number: 2143681
• Product Code: DQY
• UDI-Device Identifier: 00801741062834
• UDI-Public: (01)00801741062834
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083657
• 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): 09/18/2018

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: 06/30/2020
• Device Model Number: CQ7554
• Device Catalogue Number: CQ7554
• Device Lot Number: REBT1542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 87