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

Model Number	CQ5084
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 09/2021).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that the balloon was pulled back through the sheath and removed as single unit.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that the balloon was pulled back through the sheath and removed as single unit.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: 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.Investigation summary: one conquest pta dilatation catheter was returned for the evaluation.Visual evaluation was performed and device appeared as a bloody.No any other anomalies noted.During functional test balloon was inflated by using an in-house presto inflation device and it was able to inflate and maintain the pressure.Then balloon was deflated and its noted that its taking more time to deflate.Balloon took 39 seconds to deflate completely.Then catheter was cut at the point where no kinks were present.Then the distal segment was inflated using a touhy adapter.The balloon inflated and maintained pressure.Then the balloon was deflated and it's took 22 seconds to deflate completely.No further testing was performed.Therefore, the investigation is confirmed for the reported deflation problem , as deflation time of the balloon was above the specification of 35 seconds.A definitive root cause for the deflation problem could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 09/2021).H11:section a through f - the information provided by bd 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 bd.

• 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: 11145213
• Report Number: 2020394-2020-21039
• Device Sequence Number: 17073467
• Product Code: DQY
• UDI-Device Identifier: 00801741063060
• UDI-Public: (01)00801741063060
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/14/2021

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 Model Number: CQ5084
• Device Catalogue Number: CQ5084
• Device Lot Number: RECW0330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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: Other