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

Model Number	U35130630
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 11/2025).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 got stuck in the sheath when it was deflated to pull out of the patient.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 loaded into an unknown 6fr sheath was returned for evaluation.The balloon was noted to be loaded onto an unknown sheath and the introducer sheath was severely damaged.No other specific anomalies were noted during the visual evaluation.During functional testing, negative pressure was applied to remove the remaining air from the balloon.Further, the balloon was attempted to remove from the loaded sheath but it was unsuccessful and strong resistance was also felt.No further testing was performed due to the condition of the sample.As the returned balloon was noted to be loaded within an unknown sheath and unable to remove during the functional testing, the investigation is confirmed for the reported sheath removal difficulty.A definitive root cause for the reported sheath removal difficulty 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: 11/2025), g3.H11: h6 (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.H3 other text : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly got stuck within the sheath when deflated to pull out of the patient.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly got stuck within the slender sheath when deflated to pull of the patient.The procedure was completed using another balloon from a different vendor through the second access site.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 loaded into an unknown 6fr sheath was returned for evaluation.The balloon was noted to be loaded onto an unknown sheath and the introducer sheath was severely damaged.No other specific anomalies were noted during the visual evaluation.During functional testing, negative pressure was applied to remove the remaining air from the balloon.Further, the balloon was attempted to remove from the loaded sheath but it was unsuccessful and strong resistance was also felt.No further testing was performed due to the condition of the sample.As the returned balloon was noted to be loaded within an unknown sheath and unable to remove during the functional testing, the investigation is confirmed for the reported sheath removal difficulty.A definitive root cause for the reported sheath removal difficulty 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: 11/2025), g3, h6 (method).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: 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: 17115949
• Report Number: 2020394-2023-00422
• Device Sequence Number: 7065789
• Product Code: LIT
• UDI-Device Identifier: 00801741093258
• UDI-Public: (01)00801741093258
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 08/03/2023

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: U35130630
• Device Catalogue Number: U35130630
• Device Lot Number: CMGZ0322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 07/07/2023; 08/03/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/10/2023; 08/06/2023
• 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