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

Model Number	CQ75104
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 06/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly unable to deflate.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly unable to deflate.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the initial mdr was inadvertently submitted with g3 date as 22-may-2021.The correct g3 date is 04-may-2021.H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4(expiry date: 06/2023).H11: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.
Additional Manufacturer Narrative
H10: the initial mdr 2020394-2021-01218 was inadvertently submitted with g3 date as 22-may-2021.The correct g3 date is 04-may-2021.Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one conquest pta dilatation catheter with an unknown sheath loaded onto the catheter has returned for evaluation.On the visual evaluation of the device, it appears bloody.No specific anomalies noted.On the functional evaluation of the device, the in-house guide wire was able to insert without any issue and the balloon was attempted to inflate with the in-house presto device, but it was unsuccessful.Then the balloon was made a cut and under the microscopic observation it was noted the glue bullet was sitting inside of the inner catheter shaft and one of the port holes was noted to be deformed.No further testing performed.Therefore, the investigation for the reported deflation issue remains inconclusive as no functional testing performed and the balloon couldn¿t be able to inflate during the functional evaluation.The investigation for the reported difficult to remove as confirmed as the device loaded into a unknow sheath and returned for the evaluation.During the microscopic observation it was noted that glue bullet pushed into the inner catheter shaft and the port holes was noted to be deformed could lead to the reported deflation issue and difficult to remove.However the definitive root cause for the deflation issue and difficult to remove 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.H10: b5,d4(expiry date: 06/2023).H11: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.H3 other text : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly unable to deflate and had difficulty in removing from the patient's vein.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: CONQUEST
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12015125
• Report Number: 2020394-2021-01218
• Device Sequence Number: 11589378
• Product Code: DQY
• UDI-Device Identifier: 00801741063220
• UDI-Public: (01)00801741063220
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 08/06/2021

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: CQ75104
• Device Catalogue Number: CQ75104
• Device Lot Number: REEU4166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Received by Manufacturer: 05/22/2021
• Supplement Date Received by Manufacturer: 06/21/2021; 08/13/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 06/24/2021; 08/24/2021
• 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