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

Model Number	CQ7574
Medical Device Problem Codes	Deflation Problem (1149); Material Frayed (1262); Peeled/Delaminated (1454); Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, images were provided for review.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during an angioplasty procedure in the superficial femoral artery, the device allegedly failed to deflate.It was further reported that the physician assisted with guiding to remove it.The procedure was completed using another device.There was no reported patient injury.
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 and images were provided for review.The investigation of the reported event is currently underway.D4 (expiry date: 09/2024).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.
Event or Problem Description
It was reported that during an angioplasty procedure in the superficial femoral artery, the device allegedly failed to deflate.It was further reported that the physician assisted with guiding to remove it.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in the superficial femoral artery, the device allegedly failed to deflate.It was further reported that the physician assisted with guiding to remove it.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.Seven radiographic image was reviewed.Multiple fluoroscopic images are reviewed.These demonstrate an angioplasty balloon inflated near or just within a stent within presumably the superficial femoral artery of the left thigh.The artery proximal to the stent (in which the balloon is inflated) appears significantly calcified.Other images show this same location with now a deployed stent in place.A report describes an event in which a conquest angioplasty balloon failed to deflate after deployment.It is difficult to comment further on this event without fluoroscopic videos.The provided images show a sequence in which a balloon is inflated, and at this same location a stent is then seen in place.The artery appears significantly calcified.Therefore, based on the image review, the reported failure deflation issue could not be confirmed on the findings no conclusion can be made.Therefore the investigation for the reported deflation issue remains inconclusive as no conclusion can be made based on the submitted image review.A definitive root cause for the reported deflation issue could not be determined based upon the provided information.It is unknown whether patient and/or procedural issues contributed to the reported event.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.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 not returned.
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 pta dilatation catheter in two segments was returned for evaluation.The first segment consists of the bifurcate and the second segment consists of the remaining portion of the balloon and catheter.Peeled pebax, unraveling, and frayed fibers were also noted on the returned balloon.No other anomalies were noted during the visual evaluation.No functional testing was performed due to the condition of the device returned for evaluation.Seven radiographic image was reviewed.Multiple fluoroscopic images are reviewed.These demonstrate an angioplasty balloon inflated near or just within a stent within presumably the superficial femoral artery of the left thigh.The artery proximal to the stent (in which the balloon is inflated) appears significantly calcified.Other images show this same location with now a deployed stent in place.A report describes an event in which a conquest angioplasty balloon failed to deflate after deployment.It is difficult to comment further on this event without fluoroscopic videos.The provided images show a sequence in which a balloon is inflated, and at this same location a stent is then seen in place.The artery appears significantly calcified.Therefore, the investigation remains inconclusive for the reported deflation issue as the functional testing couldn¿t be performed due to the condition of the device returned for evaluation.The reported issue also couldn¿t be confirmed based on the submitted radiographic images.However, the investigation is confirmed for the identified detachment issue as the returned device was noted to be detached into two separate segments.The investigation is also confirmed for the identified peeled pebax, unravelling, and frayed fibers as these fiber anomalies were noted on the returned balloon during the visual evaluation.A definitive root cause for the reported deflation issue, identified detachment, peeled pebax, unravelling, and frayed 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: 09/2024), g3, h2, h6 (device, method).H11: h6 (result, conclusion).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 in the superficial femoral artery, the device allegedly failed to deflate.It was further reported that the physician assisted with guiding to remove it.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: 14546144
• Report Number: 2020394-2022-00426
• Device Sequence Number: 6736926
• Product Code: DQY
• UDI-Device Identifier: 00801741062834
• UDI-Public: (01)00801741062834
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/11/2022

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: CQ7574
• Device Catalogue Number: CQ7554
• Device Lot Number: REFX0658
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 06/30/2022; 08/09/2022; 09/09/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 07/05/2022; 09/05/2022; 09/14/2022
• 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 Sex: Unknown