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

Model Number	CQF7586
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
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 40 pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device appeared bloody and no other specific anomalies were noted.On the functional evaluation the balloon was inflated using an in house presto inflation device but it was only able to partially inflate.Additionally, balloon deflated with issues.On further balloon was cut and examined under magnification, the glue bullet was noted not to be seated in the correct position.No further testing was performed.Therefore the investigation for the reported inflation issue was confirmed as the balloon cannot fully inflated during the inflation using an in-house presto inflation device.The investigation for the identified deflation issue was also confirmed as the balloon deflated with issues during the evaluation.The pulled glue bullet noted during evaluation, most likely contributed to the reported inflation and deflation issues.However, the definitive root cause for the reported inflation issue and the identified deflation issue could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 03/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had an inflation issue.There was no reported patient injury.

• Brand Name: CONQUEST 40
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12194693
• Report Number: 2020394-2021-01353
• Device Sequence Number: 3802419
• Product Code: DQY
• UDI-Device Identifier: 00801741060564
• UDI-Public: (01)00801741060564
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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: CQF7586
• Device Catalogue Number: CQF7586
• Device Lot Number: REER2287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other