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

Model Number	CQF75104
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
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: 06/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 12atm.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 40 pta dilatation catheter has returned for evaluation.On the visual evaluation of the device, the device appeared bloody, no kinks noted on the catheter.No specific anomalies were noted.During the functional evaluation of the device, the balloon was inflated with an in-house presto inflation device, during the inflation water leaked form the pinhole ruptured region of the balloon.The balloon fibers were stripped then the pinhole rupture was noted under the microscopic observation.Therefore, the investigation for the reported balloon rupture has been confirmed as the water starts leaking from the pinhole ruptured region of the balloon during the inflation.A definitive root cause for the balloon rupture 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: 06/2023), g3, h6 (method).H11: section a through f: the information provide by bd represents all 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 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: 11875316
• Report Number: 2020394-2021-01102
• Device Sequence Number: 14285015
• Product Code: DQY
• UDI-Device Identifier: 00801741060632
• UDI-Public: (01)00801741060632
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K120660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2021

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: CQF75104
• Device Catalogue Number: CQF75104
• Device Lot Number: REEU2576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/02/2021
• 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