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

Catalog Number	CQ5074
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2025).H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured after twenty seconds of expansion.The procedure was completed by using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured after twenty seconds of expansion.The procedure was completed by using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: additional information was received, the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiry date: 08/2025), g3.H11: section a through f ¿ the information provided 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.Device pending return.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as malfunction.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 pta dilatation catheter was returned for evaluation loaded on an unknown guidewire.No kinks noted to the catheter shaft, no anomalies to the luers, bifurcate or glue fillets.Peeled pebax and fiber disturbance were noted to the distal end of the balloon.The balloon was returned slightly inflated.An attempt was made to remove the unknown guidewire but was unsuccessful.An attempt was also made to inflate the balloon but was unsuccessful.The balloon was then cut and dried contrast was noted to both portholes.Thus, testing to determine if there was a balloon rupture could not be performed.No other functional testing was performed.One photo was reviewed.The photo shows the conquest balloon deflated and bloody.No specific anomalies noted.Therefore, the investigation is inconclusive for the reported balloon rupture as testing for it could not be performed due to the condition of the returned device.However, the investigation is confirmed for the identified peeled pebax as peeled pebax and fiber disturbance were noted to the distal end of the balloon.A definitive root cause for the reported balloon rupture and identified peeled pebax could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 08/2025), g3, h2, h6 (device).H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured after twenty seconds of expansion.The procedure was completed by using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as malfunction.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 pta dilatation catheter was returned for evaluation loaded on an unknown guidewire.No kinks noted to the catheter shaft, no anomalies to the luers, bifurcate or glue fillets.Peeled pebax and fiber disturbance were noted to the distal end of the balloon.The balloon was returned slightly inflated.An attempt was made to remove the unknown guidewire but was unsuccessful.An attempt was also made to inflate the balloon but was unsuccessful.The balloon was then cut and dried contrast was noted to both portholes.Thus, testing to determine if there was a balloon rupture could not be performed.No other functional testing was performed.One photo was reviewed.The photo shows the conquest balloon deflated and bloody.No specific anomalies noted.Therefore, the investigation is inconclusive for the reported balloon rupture as testing for it could not be performed due to the condition of the returned device.However, the investigation is confirmed for the identified peeled pebax as peeled pebax and fiber disturbance were noted to the distal end of the balloon.A definitive root cause for the reported balloon rupture and identified peeled pebax could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured after twenty seconds of expansion.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: CONQUEST
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18298420
• Report Number: 2020394-2023-01211
• Device Sequence Number: 20575621
• Product Code: DQY
• UDI-Device Identifier: 00801741062957
• UDI-Public: (01)00801741062957(11)221206(17)250831(10)REGW2715
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/20/2024

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 Expiration Date: 08/31/2025
• Device Catalogue Number: CQ5074
• Device Lot Number: REGW2715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/19/2023
• Supplement Date Received by Manufacturer: 12/09/2023; 02/23/2024; 06/13/2024
• Initial Report FDA Received Date: 12/10/2023
• Supplement Report FDA Received Date: 01/05/2024; 03/07/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown