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

Model Number	CQF7594
Medical Device Problem Codes	Material Frayed (1262); Difficult to Remove (1528); Material Rupture (1546); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(expiry date: 08/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 30 atm.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one conquest 40 pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device was noted to be bloody.Frayed fibers and unraveling was noted at the proximal end of the balloon.No other specific anomalies were noted.On the functional evaluation, an in house presto inflation sample was used to inflate the sample and water was noted to be leaking at the proximal end of balloon.The balloon fibers were stripped and a longitudinal rupture was noted to the balloon at the distal tip.No evidence was noted for the difficult to remove from the evaluation.No other functional testing was performed.Therefore the investigation for the reported balloon rupture was confirmed as the water was leaking from the longitudinal ruptured region of the balloon.The investigation for the identified frayed and unraveled material was confirmed as the frayed and unraveling of the fibers were noted at the proximal end of the balloon.The investigation for the reported difficult to remove was inconclusive as the reported event cannot be replicated in the lab.A definitive root cause for the reported balloon rupture ,difficult to remove and the identified frayed, unraveled material could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, d4 (expiry date: 08/2023),.
Event or Problem Description
It was reported that during an angioplasty procedure through the left arm, the pta balloon allegedly ruptured at 30 atm.There was no reported patient injury.

• Brand Name: CONQUEST 40 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: 12082303
• Report Number: 2020394-2021-01257
• Device Sequence Number: 16981414
• Product Code: DQY
• UDI-Device Identifier: 00801741060601
• UDI-Public: (01)00801741060601
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/07/2021

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: CQF7594
• Device Catalogue Number: CQF7594
• Device Lot Number: REEW1715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 09/01/2021
• 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