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

Model Number	CQF7574
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
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.However, a photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 11/2023).
Event or Problem Description
It was reported during the angioplasty procedure at left brachy cephalic fistula, the balloon was allegedly ruptured.It was further reported another balloon was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported during the angioplasty procedure at left brachy cephalic fistula, the balloon was allegedly ruptured.It was further reported another balloon was used to complete the procedure.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 return for evaluation.Visual evaluation was performed and kink was noted at the proximal end of the inflation hub.During the performance evaluation an in house presto inflation device was used to inflate the balloon and noted that there was no water leakage from the balloon.Balloon deflated without any issue.Therefore, the investigation is confirmed for the identified kink issue as kink was noted at the proximal end of the inflation hub during visual evaluation.The investigation is unconfirmed for the reported balloon rupture issue as no rupture was noted during the functional test.One electronic photo was reviewed.Photo shows the label which contains product description such as catalogue number and lot number of the product which matches with the information in the complaint record.Therefore, based on the photo review, balloon rupture could not be confirmed.A definitive root cause for the alleged balloon rupture and identified kink issue 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: d4 (expiry date: 11/2023), h11: h6(method, result, conclusion), 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: 11963879
• Report Number: 2020394-2021-01197
• Device Sequence Number: 3724636
• Product Code: DQY
• UDI-Device Identifier: 00801741060496
• UDI-Public: (01)00801741060496
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/16/2021

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: CQF7574
• Device Catalogue Number: CQF7574
• Device Lot Number: REEZ3628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/19/2021
• 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