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

Model Number CQ7594

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Difficult to Remove (1528); Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2025).

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that the device was allegedly difficult to remove.The procedure was completed using another device.There was no reported patient injury.

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 returned for evaluation.The catheter shaft was noted to have burst, the balloon had unraveled fibers at the proximal end and the distal end of the balloon was noted to be prolapsed.No other specific anomalies were noted during the visual evaluation.No functional testing was performed due to the condition of the device returned for evaluation.Two photos were reviewed.The first photo shows the balloon in a deflated position and the catheter was noted to have ruptured near the proximal end of the balloon.No other specific anomalies were noted.The second photo shows the label of the device on which all the details can be verified with the reported product details.Therefore, the investigation remains inconclusive for the reported deflation issue as the functional testing couldn¿t be performed due to the device condition.Based on the photo review, the reported deflation issue couldn¿t be confirmed as there is no specific evidence noted.The investigation for the reported difficulty in removing the catheter from the sheath remains inconclusive as the functional testing couldn¿t be performed due to the condition of the device.Based on the photo review, the reported issue couldn¿t be confirmed as there is no specific evidence noted.However, the investigation is confirmed for the identified catheter burst as the returned catheter had a burst near the proximal end of the balloon and catheter shaft.This identified issue was also confirmed based on the submitted photo for review.The investigation is also confirmed for the identified unraveled fiber as these anomalies were noted during the visual evaluation of the returned device.A definitive root cause for the reported deflation issue, reported difficulty in removing the catheter from the sheath , identified a catheter burst and identified unraveled fiber 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: (expiry date: 02/2025).H11: section a through f ¿ the information provide 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.

• Brand Name: CONQUEST
• Type of Device: 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: 15400475
• MDR Text Key: 302725828
• Report Number: 2020394-2022-00735
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063190
• UDI-Public: (01)00801741063190
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

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
• Device Operator: Health Professional
• Device Model Number: CQ7594
• Device Catalogue Number: CQ7594
• Device Lot Number: REGQ2671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1