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

Model Number	CQ75124
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Rupture (1546); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned for evaluation.The lot history review was performed.The investigation confirmed for peeled pebax and material cut; unconfirmed for material rupture.A root cause has not been determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model cq75124 pta balloon dilatation catheter allegedly ruptured, peeled, and experienced material split, cut or torn.This report was received from one source.The patient's age, weight, and gender were not provided.There was no reported patient injury.

• 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: 9197782
• Report Number: 2020394-2019-03994
• Device Sequence Number: 16881572
• Product Code: DQY
• UDI-Device Identifier: 00801741063251
• UDI-Public: (01)00801741063251
• 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
• Report Date (Section B): 10/16/2019

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: CQ75124
• Device Catalogue Number: CQ75124
• Device Lot Number: RECX3754
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/16/2019
• Patient Sequence Number: 1