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

Model Number	CQ5054
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
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 not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 01/2025).Device evaluated by mfr: device not returned.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon was allegedly burst during pressurization with pressure pump.It was further reported that the blood vessel was damaged and recovered after compression to stop bleeding.Reportedly, damaged balloon was removed and new 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, and the investigation remains inconclusive for the reported balloon rupture, as no objective evidence of a rupture could be noted on the provided photos.Three photos were reviewed.The first and third photos show the balloon in a deflated condition.The second photo shows the device description label.No specific evidence of rupture could be observed due to the device's condition in the submitted photo.No other anomalies were noted.A definitive root cause for the reported balloon rupture 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 (expiration date: 01/2025).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.H3 other text: device not returned.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured during pressurization with pressure pump.It was further reported that blood vessel was allegedly damaged which was recovered after compression to stop bleeding.Reportedly, the damaged balloon was removed and a new balloon was used to complete the procedure.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: 16634493
• Report Number: 2020394-2023-00208
• Device Sequence Number: 14981723
• Product Code: DQY
• UDI-Device Identifier: 00801741062803
• UDI-Public: (01)00801741062803
• 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
• Report Date (Section B): 04/24/2023

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: CQ5054
• Device Catalogue Number: CQ5054
• Device Lot Number: REGP0514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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