MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRASCORE 014; PTA BALLOON DILATATION CATHETER

Model Number	US14150410
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
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.(expiration date: 07/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 2atm.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
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 ultrascore 014 pta dilatation catheter was returned for evaluation.No specific anomalies were noted during the visual evaluation of the device.In the functional testing, the balloon was inflated with the in-house presto inflation device, but it was unable to inflate.The catheter shaft was shaved, and it was observed that blood residue was noted within the catheter shaft.Due to the condition of the sample, functional testing to determine the rupture could not be conducted.All the anomalies were observed under microscopic observation.Therefore, the investigation remains inconclusive for the reported balloon rupture as the functional testing to find the rupture could not be conducted due to the condition of the device returned for evaluation.A definitive root cause for the reported balloon rupture 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 (expiration date: 07/2023), g3.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, the pta balloon allegedly ruptured at 2atm.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: ULTRASCORE 014
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14768677
• Report Number: 2020394-2022-00496
• Device Sequence Number: 14990814
• Product Code: PNO
• UDI-Device Identifier: 00801741113703
• UDI-Public: (01)00801741113703
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172571
• 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): 07/14/2022

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: US14150410
• Device Catalogue Number: US14150410
• Device Lot Number: GFFU1179
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 07/22/2022
• 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