MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	CQF7594
Medical Device Problem Codes	Burst Container or Vessel (1074); Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the events indicated that model cqf7594 pta balloon dilatation catheter allegedly experienced deflation issues during an angioplasty in a fistula.It was further reported that the catheter shaft of the pta balloon allegedly burst.The procedure was completed with another device.This report was received from one source.This event involved one male patient, (b)(6) years of age and the weight was not provided.This patient had no reported patient injury.
Additional Manufacturer Narrative
Manufacturing records were reviewed and there were not found evidence that the failure mode reported in this complaint is caused by the manufacturing process.The device was returned for evaluation.A visual inspection was performed and a burst was noted in the catheter shaft.No other anomalies were noted to the device.The balloon was unable to be inflated.Therefore, the investigation is confirmed for the reported catheter shaft burst, as the burst was noted in the catheter shaft.The deflation issue is inconclusive, as the device could not be tested for deflation.The definitive root cause for the identified burst in the catheter shaft and reported deflation issue could not be determined based upon available information.The device was labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model cqf7594 pta balloon dilatation catheter allegedly experienced deflation issues during an angioplasty in a fistula.It was further reported that the catheter shaft of the pta balloon allegedly burst.The procedure was completed with another device.This report was received from one source.This event involved one male patient, 36 years of age and the weight was not provided.This patient had no reported patient injury.

• Brand Name: CONQUEST 40 PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8510239
• Report Number: 2020394-2019-00272
• Device Sequence Number: 13820901
• Product Code: DQY
• UDI-Device Identifier: 00801741060601
• UDI-Public: (01)00801741060601
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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: No Information
• Device Model Number: CQF7594
• Device Catalogue Number: CQF7594
• Device Lot Number: RECZ2109
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1