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

Model Number	U3513084
Medical Device Problem Codes	Break (1069); Burst Container or Vessel (1074); Difficult to Insert (1316); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 09/2024).
Event or Problem Description
It was reported that during an angioplasty procedure in the right common femoral, the pta balloon was allegedly unable to be inserted through the sheath.It was further reported that the balloon ruptured and had difficulty in retracting through the introducer sheath and eventually the catheter broke off within the sheath.It was further reported that the device was removed as single unit.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 ultraverse 035 pta dilatation catheter in two segments was received for evaluation.During visual evaluation, segment 1 was noted to consist of a portion of the catheter and y-body.A complete circumferential break was noted to the catheter.No anomalies to the luers/y-body.Segment two consisted of the remaining portion of catheter and balloon within an unknown sheath.The distal tip of the sheath was noted to be buckled.No other anomalies were noted.During functional evaluation, the balloon and catheter were removed from the sheath and catheter burst was noted near the circumferential break.No other functional testing was performed.Therefore, the investigation is inconclusive for the reported sheath insertion difficulty and balloon rupture as no evidence of the failures could be determined.The investigation is confirmed for the reported sheath removal difficulty as the device was returned with a segment of the catheter within the sheath and with the distal tip of the sheath buckled.The investigation is also confirmed for the reported detachment as the device was returned in two segments.The investigation is also confirmed for the identified catheter burst as a catheter burst was noted to segment two of the detached catheter.A definitive root cause for the alleged sheath insertion difficulty, sheath removal difficulty, detachment, balloon rupture and identified catheter burst 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: 09/2024), g3, h6 (method).H11: h6 (device, result, conclusion).H11: section a through f ¿ the information provide 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 in the right common femoral, the pta balloon was allegedly unable to be inserted through the sheath.It was further reported that the balloon ruptured and had difficulty in retracting through the introducer sheath and eventually the catheter broke off within the sheath.It was further reported that the device was removed as single unit.There was no reported patient injury.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15574057
• Report Number: 2020394-2022-00790
• Device Sequence Number: 14199339
• Product Code: LIT
• UDI-Device Identifier: 00801741094170
• UDI-Public: (01)00801741094170
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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: U3513084
• Device Catalogue Number: U3513084
• Device Lot Number: CMFX0207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 11/23/2022
• 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 Age: 72 YR
• Patient Sex: Female