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

Model Number	US14150610
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
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.(expiry date: 03/2024).
Event or Problem Description
It was reported that during an angioplasty procedure in the superficial femoral artery, the pta balloon was allegedly difficult to deflate.It was further reported that the device was removed with resistance.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in the superficial femoral artery, the pta balloon was allegedly difficult to deflate.It was further reported that the device was removed with resistance from the sheath after the second inflation.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 received for evaluation.During visual evaluation, no kinks were noted to the catheter shaft and no anomalies to the luers/y-body.No other anomalies were observed.During functional testing, the sample guide-wire lumen was flushed successfully.The patency of the guide-wire lumen was tested using an in-house 0.014 guide-wire.It was then inserted and removed with no issue.An in-house presto inflation device was used to inflate the balloon to 12 atm.The balloon was inflated and maintained pressure.The balloon deflation time was approximately 17 seconds.The balloon was then cut and balloon material was noted to be covering one of the inflation ports.Therefore, the investigation is inconclusive for the reported difficult to remove as functional testing involving introducer sheath could not be performed since the balloon was cut.The investigation is unconfirmed for the reported deflation issue as the balloon deflation time was approximately 17 seconds which is within the acceptable range as per the design input requirements document.A definitive root cause for the alleged deflation issue and 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: b5, d4(expiry date: 03/2024), g3.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.

• 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: 15137396
• Report Number: 2020394-2022-00622
• Device Sequence Number: 7323560
• Product Code: PNO
• UDI-Device Identifier: 00801741114052
• UDI-Public: (01)00801741114052
• 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): 08/18/2022

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: US14150610
• Device Catalogue Number: US14150610
• Device Lot Number: GFGQ0993
• 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: 07/07/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 08/22/2022
• 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