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

Model Number	CQ7594
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly inflating slowly.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
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 in its original packaging has been received for the evaluation.On the visual evaluation, the device was noted bloody.Peeled pebax was noted at the proximal end of the balloon and no other specific anomalies were noted.On the functional evaluation, the balloon was inflated to 8 atm using an in-house presto inflation device and the balloon was maintained the pressure without any issue.Further, the balloon was deflated and it takes the deflation time of 1minute and 22 seconds which is above the maximum deflation time of 35 seconds in the product performance specification limit.Balloon was cut and the port holes were noted to be collapsed and the glue bullet was not seated in the correct position.No other functional testing performed.Under the microscopic observation, all the anomalies were noted.Therefore the investigation for the reported inflation issue was unconfirmed, as the balloon was successfully inflated during the functional evaluation.The investigation for the identified deflation issue has been confirmed, as the balloon deflation time was noted to be above the maximum deflation time in the product performance specification limit.The investigation for the identified peeled pebax was confirmed, as the peeled fibers were noted at the proximal end of the balloon.The collapsed port holes is likely the root cause for the deflation issue.However a definitive root cause for the reported inflation issue and the identified deflation issue, peeled pebax 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.(expiry date: 10/2023).

• Brand Name: CONQUEST
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12891256
• Report Number: 2020394-2021-02017
• Device Sequence Number: 11123016
• Product Code: DQY
• UDI-Device Identifier: 00801741063190
• UDI-Public: (01)00801741063190
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 11/03/2021

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: CQ7594
• Device Catalogue Number: CQ7594
• Device Lot Number: REEY2463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/30/2021
• 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 Age: 67 YR
• Patient Sex: Female