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

Catalog Number	0284514
Medical Device Problem Codes	Break (1069); Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a valvuloplasty procedure, the ptv balloon allegedly partially separated at the shaft and the balloon allegedly wasn't completely deflated.It was further reported that the actual balloon was still connected via the lumen to fill the balloon.Furthermore, it was allegedly hard to remove through the sheath.Reportedly, it was removed all together and the procedure was completed using another balloon.There was no reported injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be 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.H3 other text : device pending return.
Event or Problem Description
It was reported that during a valvuloplasty procedure, the ptv balloon allegedly partially separated at the shaft.It was further reported that the actual balloon was still connected via the lumen to fill the balloon.Furthermore, it was allegedly hard to remove through the sheath.Reportedly, it was removed all together and the procedure was completed using another balloon.There was no reported 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 true ptv dilatation catheter was received for evaluation.A complete circumferential break to the distal end of the catheter shaft proximal to balloon was noted.During visual analysis, the balloon was noted to be separated from the catheter shaft at the proximal end leaving the inner guidewire lumen exposed.No other anomalies were noted.Due to the condition of the device, no functional testing was performed.Based on the received sample visual analysis, a catheter shaft break with the inner guidewire lumen in the proximal end of balloon could be observed, further the balloon was attached with the inner guidewire lumen moved distal to the balloon could be noted.Therefore, the investigation is confirmed for the reported break and difficult to removal issues.A definitive root cause for the reported break and difficult to removal issues 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).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.

• 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: 19123674
• Report Number: 2020394-2024-00527
• Device Sequence Number: 8359457
• Product Code: OZT
• UDI-Device Identifier: 00801741097478
• UDI-Public: (01)00801741097478
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 06/06/2024

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 Catalogue Number: 0284514
• Device Lot Number: GFHU0615
• 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: 04/01/2024
• Supplement Date Received by Manufacturer: 07/04/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 07/19/2024
• 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
• Patient Sex: Unknown