MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	CQF7584
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2023).
Event or Problem Description
It was reported that during an angioplasty procedure on left upper arm fistula via left cephalic arch approach, the balloon allegedly ruptured.It was further reported that another balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.H10: as the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: (expiry date: 10/2023).H11: section a through f ¿ 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 an angioplasty procedure on left upper arm fistula via left cephalic arch approach, the balloon allegedly had pin hole on inflation portion hub.It was further reported that another balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the reportability of the file was changed to malfunction based on the additional information received.H10: as the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2023).H11: section a through f ¿ 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 an angioplasty procedure on left upper arm fistula via left cephalic arch approach, the balloon allegedly had pin hole on inflation portion hub.It was further reported that another balloon was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure on left upper arm fistula via left cephalic arch approach, the balloon allegedly had pin hole on inflation portion hub.It was further reported that another balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one conquest 40 pta dilatation catheter ha been returned for evaluation.On the visual evaluation of the device, it appeared bloody, no specific anomalies noted.On the functional evaluation of the device an in-house guide wire was inserted through the flushed guide wire lumen without any issue.On further the balloon was trying to inflate, with in-house presto inflation device, while inflating the balloon.Water lakes out from the proximal glue join of the catheter, then balloon deflated without any issue.On the microscopic evaluation confirm water exited out through the glue joint of the catheter and the appeared to be partially lifted.Therefore, the investigation is conformed for the reported break and leak as the water leaks from the glue joint when did balloon try to inflate.A definitive root cause for the alleged leak and break could not be determined based upon the provided 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.H10: d4 (expiry date: 10/2023).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.

• Brand Name: CONQUEST 40 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: 11449746
• Report Number: 2020394-2021-00493
• Device Sequence Number: 4049008
• Product Code: DQY
• UDI-Device Identifier: 00801741060557
• UDI-Public: (01)00801741060557
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K120660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/01/2021

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: CQF7584
• Device Catalogue Number: CQF7584
• Device Lot Number: REEY3370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 02/27/2021; 03/31/2021; 04/27/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 03/26/2021; 04/27/2021; 05/10/2021
• 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
• Patient Age: 65 YR
• Patient Weight: 73