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

Model Number	CQF7574
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(expiry date: 03/2022).
Event or Problem Description
It was reported during an angioplasty procedure at left brachycephalic fistula, the balloon allegedly ruptured.It was further reported the balloon was allegedly difficult to be removed.The procedure was completed by using another device.There was no reported patient injury.
Event or Problem Description
It was reported during an angioplasty procedure at left brachycephalic fistula, the balloon allegedly ruptured.It was further reported that the balloon was allegedly difficult to be removed.The procedure was completed by using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 40 pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device was noted to have the blood residues and no other anomalies were noted to the device.On the functional evaluation, the guidewire lumen was flushed and an inhouse guidewire was able to be inserted without any issues.The introducer sheath was flushed and the device was not fully loaded onto the sheath.On further, the balloon was inflated using an inhouse presto inflation device and the water was noted to be leaking from the balloon upon inflation.Then the balloon fibers were stripped off and a longitudinal was noted under the microscopic observation.Therefore the investigation for the reported balloon rupture was confirmed, as the longitudinal rupture was noted on the balloon under the microscopic observation.The investigation for the reported difficult to remove remains inconclusive, as functional testing could not be formed due to the device unable to load into the in-house sheath.The investigation for the identified difficult to insert was confirmed, as the balloon was unable to be loaded onto the in-house sheath.A definitive root cause for the balloon rupture, difficult to remove and the identified difficult to insert 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: 03/2022), g3, h6 (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.H3 other text : see h10.
Event or Problem Description
It was reported during an angioplasty procedure at left brachycephalic fistula, the balloon allegedly ruptured.It was further reported that the balloon was allegedly difficult to be removed.The procedure was completed by using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 40 pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device was noted to have the blood residues and no other anomalies were noted to the device.On the functional evaluation, the guidewire lumen was flushed and an inhouse guidewire was able to be inserted without any issues.The introducer sheath was flushed and the device was not fully loaded onto the sheath.On further, the balloon was inflated using an inhouse presto inflation device and the water was noted to be leaking from the balloon upon inflation.Then the balloon fibers were stripped off and a longitudinal was noted under the microscopic observation.Therefore the investigation for the reported balloon rupture was confirmed, as the longitudinal rupture was noted on the balloon under the microscopic observation.The investigation for the reported difficult to remove remains inconclusive, as functional testing could not be formed due to the device unable to load into the in-house sheath.The investigation for the identified difficult to insert was confirmed, as the balloon was unable to be loaded onto the in-house sheath.A definitive root cause for the balloon rupture, difficult to remove and the identified difficult to insert 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: 03/2022), 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12458101
• Report Number: 2020394-2021-01672
• Device Sequence Number: 11073845
• Product Code: DQY
• UDI-Device Identifier: 00801741060496
• UDI-Public: (01)00801741060496
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 12/13/2021

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: CQF7574
• Device Catalogue Number: CQF7574
• Device Lot Number: REDR4146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 10/11/2021; 11/30/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/13/2021; 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2019
• 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