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

Catalog Number	CQ7574
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
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 pta dilatation catheter was received for evaluation.The sample appeared to have residue throughout.An in-house presto inflation device was used to inflate the balloon and water was noted streaming from the catheter shaft.Water was also noted streaming from the proximal end of the balloon.The balloon fibers were stripped and under microscopic examination, a partial compound rupture was noted to the balloon.Break was also noted to the inner guidewire lumen.No other functional testing performed.One photo was provided and reviewed.The photo shows the conquest device being held in a transparent bag.The inner packaging of the device can also be seen.Residue is seen on the balloon.No specific anomalies noted.Therefore, the investigation is confirmed for the reported balloon rupture as a compound rupture was noted to the balloon.The investigation is also confirmed for the identified inner guidewire lumen break as a break was noted to the inner guidewire lumen.A definitive root cause for the reported balloon rupture and identified inner guidewire lumen break 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 (expiry date: 04/2026) 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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly blast at 22 atm.Further it was reported that the balloon was removed from the sheath and the balloon was allegedly found to be leaking.The procedure was completed using another balloon.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: 19792191
• Report Number: 2020394-2024-01075
• Device Sequence Number: 7096780
• Product Code: DQY
• UDI-Device Identifier: 00801741062995
• UDI-Public: (01)00801741062995
• 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
• Report Date (Section B): 07/04/2024

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 Catalogue Number: CQ7574
• Device Lot Number: REHS4635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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