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

Model Number	CQ7564
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the two reported malfunctions was provided, therefore, lot history reviews were performed.The devices were not returned to the manufacturer for evaluation/inspection.Therefore, the investigation for the two reported malfunctions are inconclusive for the alleged material rupture issue.Based on the available information, the definitive root cause is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicates the model cq7564 pta balloon dilatation catheter allegedly experienced material rupture.The report was received from various source.Both malfunctions were involved patient with no known impact to the patient.Of the two reported malfunctions, one male patient is (b)(6) years old and weighs (b)(6) kgs.The remaining patient's age, gender and weight was not provided.
Additional Manufacturer Narrative
H10: of the 2 reported malfunctions, 1 was reassessed for reportability and determined to be no longer reportable.The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The devices was not returned to the manufacturer for evaluation/inspection.Therefore, the investigation is inconclusive for the alleged material rupture issue.Based on the available information, the definitive root cause is unknown.The devices is labeled for single use.Section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates the model cq7564 pta balloon dilatation catheter allegedly experienced material rupture.This report was received from one source.The event involved a patient with no known impact to the patient.The patient age, gender and weight was not provided.

• 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: 10752612
• Report Number: 2020394-2020-06234
• Device Sequence Number: 13734466
• Product Code: DQY
• UDI-Device Identifier: 00801741062902
• UDI-Public: (01)00801741062902
• 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): 04/05/2021

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: No Information
• Device Model Number: CQ7564
• Device Catalogue Number: CQ7564
• Device Lot Number: REBX1144
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 04/05/2021
• Patient Sequence Number: 1