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

Model Number	U3575530
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history 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: 05/2023).
Event or Problem Description
It was reported that during an angioplasty procedure through the superficial femoral artery to treat the lower limb, the distal part of the balloon caught on the sheath and was unable to remove from the patient after deflation.It was further reported that physician pulled the balloon from the patient very hard which caused the arterial damage.Another sheath was used to tamponade the damaged artery and the patient was reported to be in stable condition.
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: 05/2023).
Event or Problem Description
It was reported that during an angioplasty procedure through the superficial femoral artery to treat the lower limb, the distal part of the balloon caught on the sheath and was unable to remove from the patient after deflation.It was further reported that physician pulled the balloon from the patient very hard which caused the arterial damage.Another sheath was used to tamponade the damaged artery and the patient was reported to be in stable condition.
Event or Problem Description
It was reported that during an angioplasty procedure through the superficial femoral artery to treat the lower limb, the distal part of the balloon caught on the sheath and was unable to remove from the patient after deflation.It was further reported that physician pulled the balloon from the patient very hard which caused the arterial damage.Another sheath was used to tamponade the damaged artery and the patient was reported to be in stable condition.
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, no kinks were noted to the catheter shaft and no anomalies to the luers/y-body.No bends were noted to the catheter.The distal tip of the balloon was noted to be prolapsed.The returned unknown sheath was noted to be buckled at the distal tip and bends were noted throughout.During functional testing, the sample guidewire lumen was flushed.The patency of the guidewire lumen was tested using an in-house guidewire and was able to be inserted without issues.An in-house syringe was used flush the in-house introducer sheath without any issues.The balloon was unable to be fully inserted.No other functional testing was performed.Therefore, the investigation is confirmed for the reported difficult to remove as the distal tip of the balloon was noted to be prolapsed and the unknown sheath was buckled at its distal tip during visual evaluation of returned sample.A definitive root cause for the alleged failure 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: d4 (expiry date: 05/2023), 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.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13598536
• Report Number: 2020394-2022-00128
• Device Sequence Number: 5947080
• Product Code: LIT
• UDI-Device Identifier: 00801741092534
• UDI-Public: (01)00801741092534
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 03/24/2022

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: U3575530
• Device Catalogue Number: U3575530
• Device Lot Number: CMET0496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 04/05/2022
• 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