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

Model Number	CQF75104
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
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 return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2025).
Event or Problem Description
It was reported that during an angioplasty procedure for mid cephalic vein lesion, the pta balloon allegedly ruptured.It was further reported that when the balloon was attempted to remove from the patient, the balloon became stuck in the sheath.Reportedly, the balloon and sheath were removed as one over the wire.The procedure was completed by using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure for mid cephalic vein lesion, the pta balloon allegedly ruptured.It was further reported that when the balloon was attempted to remove from the patient, the balloon became stuck in the sheath.Reportedly, the balloon and sheath were removed as one over the wire.The procedure was completed by using another device.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 loaded into the unknown sheath was returned for evaluation.The balloon noted to be rupture circumferentially and the distal end of the balloon to be prolapsed and bunched.Unravelling of fibers was also noted.No other anomalies during the visual evaluation.No functional testing performed due to the condition of the device.As the returned catheter was noted to be loaded with the unknown sheath and the balloon had a circumferentially ruptured.Therefore the investigation was confirmed to the reported balloon rupture and difficult to remove through the sheath.The investigation was also confirmed for the identified unraveled fibers, as these anomalies was able to observe on the returned device.One photo reviewed.The photos shows the catheter within the inner package, and the products details could be verified with the reported event.No specific damage could be noted.Therefore no investigation conclusion made for the reported event.A definitive root cause for the reported balloon rupture and difficult to remove from sheath and identified unraveled fibers 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: d4 (expiry date: 08/2025), g3, h6 (device).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.

• Brand Name: CONQUEST 40
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16535754
• Report Number: 2020394-2023-00171
• Device Sequence Number: 20335324
• Product Code: LIT
• UDI-Device Identifier: 00801741060632
• UDI-Public: (01)00801741060632
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2023

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: CQF75104
• Device Catalogue Number: CQF75104
• Device Lot Number: REGW1406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 84 KG