MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; BALLOON VALVULOPLASTY CATHETER

Catalog Number	0284514
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
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.The investigation of the reported event is currently underway.H10: d4 (expiration date: 07/2026).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 a valvuloplasty procedure, the ptv balloon allegedly ruptured.It was further reported that the balloon allegedly detached and the physician was allegedly unable to pull the balloon out of the sheath.Reportedly, a right common femoral artery exploration was made for foreign body removal through the common femoral vein longitudinal venotomy, and primary repair of right common femoral vein venotomy was performed to remove device and repair vasculature.The current status of the patient is unknown.
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 failure as no objective evidence was provided for review.A definitive root cause for the reported balloon rupture, balloon break and sheath removal issue 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: 07/2026), g3, h6 (method).H11: h6 (device, 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 a valvuloplasty procedure, the ptv balloon allegedly ruptured.It was further reported that the balloon allegedly detached and the physician was allegedly unable to pull the balloon out of the sheath.Reportedly, a right common femoral artery exploration was made for foreign body removal through the common femoral vein longitudinal venotomy, and primary repair of right common femoral vein venotomy was performed to remove device and repair vasculature.The current status of the patient is unknown.
Additional Manufacturer Narrative
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 true dilatation pta dilatation catheter was returned for evaluation.On the visual evaluation, the balloon had a break from the proximal end of the catheter, exposing the inner guide wire lumen and port hole and the balloon was still intact with the distal tip and to the catheter.No other anomalies were noted, and no functional testing could be performed due to the condition of the device.As the balloon had a break from the proximal end of the catheter which was still intact to catheter and no objective evidence of balloon rupture could be noted due to device condition and functional testing was also not performed.Hence, the investigation is confirmed for the reported break.However, the investigation remains inconclusive for the reported balloon rupture and sheath removal issue.A definitive root cause for the reported balloon rupture, balloon break and sheath removal issue 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.(expiration date: 07/2026) 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 a valvuloplasty procedure, the ptv balloon allegedly ruptured.It was further reported that the balloon allegedly detached from the catheter shaft but stayed attached at the tip which caused it to fold over itself and prevented removal from the vein.Furthermore, the physician was allegedly unable to pull the balloon out of the sheath.Reportedly, a right common femoral artery exploration was made for foreign body removal through the common femoral vein longitudinal venotomy, and primary repair of right common femoral vein venotomy was performed to remove the device and repair vasculature.The current status of the patient is unknown.

• Brand Name: TRUE DILATATION CATHETER
• Common Device Name: BALLOON VALVULOPLASTY 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: 18564074
• Report Number: 2020394-2024-00084
• Device Sequence Number: 12793330
• Product Code: OZT
• UDI-Device Identifier: 00801741097478
• UDI-Public: (01)00801741097478
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150667
• 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): 04/12/2024

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 Catalogue Number: 0284514
• Device Lot Number: GFHU0623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 03/12/2024; 04/12/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 03/23/2024; 04/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown