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

Model Number	CQ12064
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2024) 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.H3 other text : device pending return.
Event or Problem Description
It was reported that during an angioplasty procedure, pta balloon allegedly stuck in the sheath upon removal.It was further reported that balloon was allegedly unable to be removed.Reportedly the patient was punctured additionally in another site and surgical intervention was performed to complete the procedure.The current status of the patient was unknown.
Additional Manufacturer Narrative
Additional information was received, and the file was reassessed for reportability and determined to be reportable as malfunction.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 pta dilatation catheter was returned for evaluation.It was noted that the catheter was noted to be loaded with an unknown sheath and guide wire.The sheath was noted to be bunched and the distal end of the balloon was noted to be kinked.No other specific anomalies were noted during the visual evaluation.During the functional testing, a negative pressure was applied to remove the remaining air from the balloon.A huge force was applied to remove the loaded sheath from the catheter but it was unsuccessful.During the testing, the catheter was stretched inadvertently.The inserted guide wire was removed from the catheter without any problems.No further testing was performed.As the returned catheter was noted to be loaded within an unknown sheath and unable to be removed during the visual evaluation, the investigation for the reported sheath removal difficulty was confirmed.A definitive root cause for the reported sheath removal difficulty 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.D4 (expiry date: 10/2024).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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly stuck in the sheath upon removal.It was further reported that balloon was allegedly unable to be removed through the sheath.Reportedly sheath and balloon were removed intact and an additional access site was used to complete the procedure.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
• 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: 17078405
• Report Number: 2020394-2023-00399
• Device Sequence Number: 14006461
• Product Code: DQY
• UDI-Device Identifier: 00801741062933
• UDI-Public: (01)00801741062933
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: CQ12064
• Device Catalogue Number: CQ12064
• Device Lot Number: REFY0708
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/24/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown