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

Model Number	US3513058
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the device was allegedly could not be retrieved through sheath.It was further reported that the device was allegedly stuck in sheath.There was no reported patient 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.(expiration date: 08/2023).
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 035 pta dilatation catheter loaded onto an unknown sheath was returned for evaluation.On the visual evaluation, the catheter had a pinch at the entry of the introducer sheath, the sheath noted to be detached from its hub.No other anomalies were noted on the pta catheter.No functional testing was performed due to the condition of the sample.The investigation for reported difficult to remove was confirmed as the catheter was loaded unknown sheath and returned for evaluation.A definitive root cause for the reported 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: d4 (expiration date: 08/2023), 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 device was allegedly could not be retrieved through sheath.It was further reported that the device was allegedly stuck in sheath.There was no reported patient injury.

• Brand Name: ULTRASCORE 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): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13951268
• Report Number: 2020394-2022-00237
• Device Sequence Number: 11881396
• Product Code: PNO
• UDI-Device Identifier: 00801741116766
• UDI-Public: (01)00801741116766
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/06/2022

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: US3513058
• Device Catalogue Number: US3513058
• Device Lot Number: GFFU1876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 05/07/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 05/10/2022
• 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