MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035; PTA BALLOON DILATATION CATHETER

Model Number	U357546
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Perforation of Vessels (2135); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/07/2022
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 return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 11/2024).Device pending return.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 18 atm.It was further reported that the distal fragment of the catheter was wedged at the fav loop and became detached.Reportedly, the detached fragment was removed surgically and the patient experienced pain and vessel trauma.The current patient status 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 ultraverse 035 pta dilatation catheter was received for evaluation.During visual evaluation, a portion of the detached balloon was noted at the proximal end and remaining detached balloon was not returned leaving the inner guidewire lumen exposed.No kinks were noted to the catheter shaft and no anomalies noted to the luers-y-body.Functional evaluation was not performed due to the condition of the returned device.Therefore, the investigation is confirmed for the reported detachment and complete circumferential balloon rupture as the sample was returned with a portion of the balloon completely detached.However, the investigation is inconclusive for the reported removal difficulty and entrapment as the conditions for use could not be replicated in the laboratory.A definitive root cause for the reported complete circumferential balloon rupture, removal difficulty, entrapment and detachment 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: 11/2024), g3, h6 (device) h11: h6 (method, 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 that during an angioplasty procedure, the pta balloon allegedly ruptured at 18 atm.It was further reported that the distal fragment of the catheter was wedged at the fav loop and became detached.Reportedly, the detached fragment was removed surgically and the patient experienced pain and vessel trauma.The current patient status is unknown.

• Brand Name: ULTRAVERSE 035
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16076230
• Report Number: 2020394-2022-01033
• Device Sequence Number: 6159926
• Product Code: LIT
• UDI-Device Identifier: 00801741091964
• UDI-Public: (01)00801741091964
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K142261
• 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): 02/17/2023

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: U357546
• Device Catalogue Number: U357546
• Device Lot Number: CMFZ0037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 02/28/2023
• 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