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

Model Number	VA80104
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135); Swelling/ Edema (4577)
Date of Event	03/29/2022
Type of Reportable Event	Serious 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.The investigation of the reported event is currently underway.(expiry date: 12/2024).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly burst at 12 atm.It was further reported that the device had retraction issue.Reportedly patient experienced vessel injury, bleeding, right side chest and shoulder swollen and bruised.The procedure was completed by using another device.Current status of the patient is unknown.
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 vaccess pta dilatation catheter balloon loaded onto a 6fr sheath was returned for evaluation.No other specific anomalies noted during visual evaluation apart form the sheath noted to be buckled.The balloon was unable to be removed from the sheath.No functional testing was performed due to the condition of the device returned.Therefore, the investigation is confirmed for the reported difficult to remove as the was catheter noted to stuck within the introducer sheath, and was unable to be removed during the evaluation.However, the investigation for the reported balloon rupture remains inconclusive as no functional testing could not be performed as the balloon was unable to remove from the returned introducer sheath.A definitive root cause for the reported balloon rupture and difficult to remove 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: b5, d4 (expiry date: 12/2024), g3, h6(method) h11: g1, h6 (result, conclusion) 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 : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 12atm and caused vessel trauma in the patient.It was further reported that the balloon was allegedly difficult to remove from the sheath.Reportedly, the device and the introducer sheath were removed as one unit and the procedure was completed using another device.The patient experienced bleeding and the right side chest and shoulder was swollen and bruised.The current status of the patient is unknown.

• Brand Name: VACCESS
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14202163
• Report Number: 2020394-2022-00321
• Device Sequence Number: 14542545
• Product Code: LIT
• UDI-Device Identifier: 00801741121258
• UDI-Public: (01)00801741121258
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K111850
• 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): 05/23/2022

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: VA80104
• Device Catalogue Number: VA80104
• Device Lot Number: 93ZF0101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 05/25/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown