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

Model Number	CQ7588
Medical Device Problem Codes	Deflation Problem (1149); Material Frayed (1262); Peeled/Delaminated (1454)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Additional 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.The investigation of the reported event is currently underway.(expiry date: 08/2022).
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly failed to deflate.It was further reported that a percutaneous needle stick was used to deflate the balloon.The patient status was normal.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly failed to deflate.It was further reported that a percutaneous needle stick was used to deflate the balloon.The patient status was normal.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted and it was determined that a device history record review was not required.Investigation summary: the device was returned for evaluation.A visual inspection found peeled pebax and frayed fibers on the outside of the balloon.An attempt was made to inflate the balloon, however a compound rupture was noted on the balloon.Therefore, the investigation is confirmed for peeling pebax, frayed fibers, and for a compound rupture.However, the investigation is inconclusive for the reported deflation issue as the balloon was unable to be inflated to functionally test for the deflation issue.It is possible that the identified balloon rupture could have contributed to the reported deflation issue and identified frayed fibers and pebax peeling.However, the definitive root cause for the identified failures cold not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4(expiry date: 08/2022),.

• Brand Name: CONQUEST 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: 10418752
• Report Number: 2020394-2020-05411
• Device Sequence Number: 3190410
• Product Code: DQY
• UDI-Device Identifier: 00801741063138
• UDI-Public: (01)00801741063138
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CQ7588
• Device Catalogue Number: CQ7588
• Device Lot Number: REDW3546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 11/30/2020
• 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: Required Intervention