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

Model Number	CQF7574
Medical Device Problem Codes	Difficult to Remove (1528); 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 not provided, a review of the device history records could not be performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported during the angioplasty procedure at left brachy cephalic fistula, the balloon was allegedly rupture.It was further reported balloon was allegedly difficult to remove.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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the balloon rupture and difficult to remove 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: 03/2022).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.H3 other text: device not returned.
Event or Problem Description
It was reported during an angioplasty procedure of the left brachy cephalic fistula, the balloon allegedly ruptured.It was further reported the balloon was allegedly difficult to be removed.The procedure was completed by using another device.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 been received for the evaluation.On the visual evaluation, the device was noted to have the blood residues and no other anomalies were noted to the device.On the functional evaluation, the guidewire lumen was flushed and an in-house guidewire was able to be inserted without any issues.The in-house sheath was flushed and the device was able to be inserted and exited out of the sheath without any issue.On further, the balloon was inflated using an in-house presto inflation device and the water was noted to be leaking from the balloon upon inflation.Then the balloon fibers were stripped off and a pinhole rupture was noted under the microscopic observation.Balloon was retracted through the in-house sheath without any issue.Therefore the investigation for the reported balloon rupture was confirmed, as the pinhole rupture was noted on the balloon under the microscopic observation.The investigation for the reported difficult to remove was unconfirmed as the device able to be inserted and removed from the in-house sheath without any issue during the functional evaluation.A definitive root cause for the balloon rupture and difficult to remove 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: 03/2022), g3.H11: h6 (method, result).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.H3 other text : see h10.
Event or Problem Description
It was reported during an angioplasty procedure at left brachycephalic fistula, the balloon allegedly ruptured.It was further reported the balloon was allegedly difficult to be removed.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: CONQUEST 40
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11953753
• Report Number: 2020394-2021-01185
• Device Sequence Number: 4247276
• 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,Followup
• Report Date (Section B): 10/03/2021

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: REDR4146
• 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: 06/14/2021; 10/05/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 06/25/2021; 10/07/2021
• 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