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

Catalog Number	US35130512
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4: (expiration date: 10/2025).H11: section a: through f: the information provided 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.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly unable to be retrieved from the sheath.It was further reported that the pta balloon allegedly snapped remaining inside the sheath and the residual catheter slipped out slightly upon withdrawing the sheath.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one ultrascore 35 dilatation catheter was received in two segments with a sheath loaded onto the balloon for evaluation.The balloon protector was on the catheter shaft.Complete circumferential detachment was noted to the distal end of the catheter shaft and the scoring wires.The distal catheter segment included the balloon protruding out of the distal end of the introducer sheath.Deformation was noted to the distal part of the catheter segment.Bunching was noted to the distal end of the balloon.Due to the nature of the complaint, functional testing was not performed.Also, one photo was reviewed.The photo shows the ultrascore 035 device and an introducer sheath.Blood residue is seen within and on both devices.The ultrascore device is seen completely detached with the distal part of the catheter including the balloon protruding out of the distal end of the introducer sheath.The scoring wires are also seen completely detached.Therefore, the investigation is confirmed for the reported detachment and sheath removal difficulty as the device was returned in two segments with a sheath loaded onto the balloon.The investigation is also confirmed for the identified material deformation as deformation was noted to the shaft and bunching was noted to the balloon.A definitive root cause for the alleged detachment, sheath removal difficulty and identified material deformation could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 10/2025), g3, h6 (device).H11: h6 (method, result, conclusion).H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly unable to be retrieved from the sheath.It was further reported that the balloon allegedly got snapped and remained inside the sheath.Reportedly, the residual catheter allegedly slipped out slightly upon withdrawing the sheath.The procedure was completed using another device.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18836741
• Report Number: 2020394-2024-00313
• Device Sequence Number: 7439043
• Product Code: PNO
• UDI-Device Identifier: 00801741116780
• UDI-Public: (01)00801741116780
• 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): 06/06/2024

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 Catalogue Number: US35130512
• Device Lot Number: GFHX0440
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 06/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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