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

Model Number	CQF7584
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
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 balloon catheter was returned for evaluation.The returned sample was noted to have blood residue throughout and the balloon appeared to be partially inflated.No other anomalies were noted.During functional evaluation, balloon is deflated using an in house presto device.On successful deflation, an in house presto inflation device was used to inflate the balloon and water was noted to be leaking.Balloon fiber were stripped and upon microscopic magnification, a circumferential rupture was noted on the balloon.No other functional testing was done.The investigation for reported balloon rupture is confirmed, since water is noted to leaking from circumferential rupture while inflating the device during functional testing.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.(expiry date: 01/2024).
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly ruptured.There was 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 85281
• MDR Report Key: 12258304
• Report Number: 2020394-2021-01412
• Device Sequence Number: 14373191
• Product Code: DQY
• UDI-Device Identifier: 00801741060557
• UDI-Public: (01)00801741060557
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 07/22/2021

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: CQF7584
• Device Catalogue Number: CQF7584
• Device Lot Number: REFP2255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/02/2021
• 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