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

Model Number	DR4054
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
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: 05/2024).
Event or Problem Description
It was reported that during an angioplasty procedure, saline allegedly leaked from the tip of the balloon.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, saline allegedly leaked from the tip of the balloon.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one dorado pta dilatation catheter with an unknown inflation device and one syringe were returned for evaluation.On visual evaluation of the device, no other specific anomalies were noted.On functional evaluation, the device was inflated with the returned inflation device at 10 atm and maintained pressure; on further inflation up to 20 atm, leaks were noted at the catheter bond joint.Microscopic observation was performed and a break was noted at the proximal glue joint.Four images were reviewed.The four images from an angioplasty procedure in the forearm are reviewed.They demonstrate inflation of an angioplasty balloon in the distal forearm with extravasation of contrast material from the balloon, suggestive of balloon rupture.As per the reported event, the angioplasty balloon leaked contrast during inflation.This is confirmed with the provided images.Therefore, the investigation for the reported leak is confirmed as water was leaking from the bond joint during the evaluation of the returned device.The reported event can be also confirmed and observed on the provided images for review.The investigation is also confirmed for the identified bond joint break as a break at the proximal glue joint was able to be observed under microscopic observation.A definitive root cause for the reported leak and identified bond joint break could not be determined based upon the provided information.H10: d4 (expiry date: 05/2024), g3, h6 (method) 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.

• Brand Name: DORADO
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15948605
• Report Number: 2020394-2022-00973
• Device Sequence Number: 6371601
• Product Code: LIT
• UDI-Device Identifier: 00801741058486
• UDI-Public: (01)00801741058486
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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: DR4054
• Device Catalogue Number: DR4054
• Device Lot Number: 93SF0092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 12/25/2022
• 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 Sex: Unknown