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

Model Number	CQ75124
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 08/2022).The information provide by bd represents all 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
It was reported that during an angioplasty procedure in the central venous system, the balloon allegedly failed to deflate under fluoroscopy.It was further reported that the surgeon had to tug on balloon to get it from the central veins to the peripheral on the patients arm and used needle to deflate.Reportedly the balloon deflated and was removed with a sheath.The patient status was normal.
Event or Problem Description
It was reported that during an angioplasty procedure in the central venous system, the balloon allegedly failed to deflate under fluoroscopy.It was further reported that the surgeon had to tug on balloon to get it from the central veins to the peripheral on the patients arm and used needle to deflate.Reportedly the balloon deflated and was removed with a sheath.The patient status was normal.
Additional Manufacturer Narrative
Manufacturing review: a complaint history review was performed.This is the fifth complaint reported for this product/lot number combination.However, device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one device was returned for evaluation.The device was visually evaluated and was noted to be prolapsed at the distal end.The balloon was unsuccessfully attempted to be inflated with an in house presto device.The balloon was then cut and inspected under the microscope.Under magnification, the inflation portholes were noted to be proximally moved into the catheter moreover dried blood was noted inside the portholes.No further evaluation was performed.Therefore, the investigation is inconclusive for the reported inflation issue, as the reported failure mode could not be evaluated for due to the condition of the device.However, the definitive root cause for the reported deflation issue could not be determined based upon available 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: 08/2022.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.

• 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: 10926696
• Report Number: 2020394-2020-20719
• Device Sequence Number: 19643703
• Product Code: DQY
• UDI-Device Identifier: 00801741063251
• UDI-Public: (01)00801741063251
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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: CQ75124
• Device Catalogue Number: CQ75124
• Device Lot Number: REDW0248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 05/07/2021
• 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: Required Intervention