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

Model Number	U41502H22
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 12/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly ruptured.It was further reported the device allegedly had catheter break and retraction issue.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly ruptured.It was further reported the device allegedly had catheter break and retraction issue.Patient current status is unknown.
Additional Manufacturer Narrative
H10: the initial mdr was inadvertently submitted with a g3 date of (b)(6) 2021.The correct g3 date is (b)(6) 2021.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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failures as no objective evidence was provided for review.Per the reported event details, the target lesion was highly calcified.Therefore, it is possible the interaction between the lesion and the balloon contributed to the reported balloon rupture.However, the definitive root cause for the reported balloon rupture, detachment of device and difficult to remove could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 12/2023), g3, h6 (method).H11: b5, h1, h6 (patient, 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.
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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failures as no objective evidence was provided for review.A definitive root cause for the reported balloon rupture, detachment of device and difficult to remove could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: b5, d4 (expiry date: 12/2023), g3.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 a angioplasty the pta balloon allegedly ruptured.Reportedly, the health care provider allegedly experienced difficulty removing the balloon and the catheter broke.It was further reported that a fragment of the catheter was removed using a snare and the remaining fragments remained in the patient.The current patient status is unknown.

• Brand Name: ULTRAVERSE 014 PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11954230
• Report Number: 2020394-2021-01188
• Device Sequence Number: 4420898
• Product Code: LIT
• UDI-Device Identifier: 00801741053658
• UDI-Public: (01)00801741053658
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: U41502H22
• Device Catalogue Number: U41502H22
• Device Lot Number: CMFN0010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/07/2021; 07/28/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/17/2021; 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention