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

Model Number	DR8068
Medical Device Problem Codes	Break (1069); Material Frayed (1262); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2020
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 return of the sample is pending, however, a photo was provided for review.The investigation of the reported event is currently underway.Expiry date (12/2022).Return of the sample is pending.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 20 atm.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure through superficial femoral artery, the pta balloon allegedly ruptured at 20 atm.The procedure was completed using another device.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 dorado pta device was returned for evaluation.One electronic photo was provided for review.The photo shows a dorado label referring catalog number dr8068 and lot number 93yd0158.Based on the photo reviewed, no confirmation can be made.Visual evaluation was performed, sample was bloody and frayed material was noted.Functional evaluation was performed using an-in-house presto device, and water was noted to be leaking.Under microscopic examination leakage was noted to be from a partial circumferential break at the balloon joint.No rupture or leakage was noted in the area of frayed material.Therefore the investigation is confirmed for the identified frayed material, as frayed material was noted to the balloon under microscopic evaluation.The investigation is also confirmed for the reported break, as a circumferential break was noted to balloon joint.The investigation is unconfirmed for the reported material rupture as no rupture was noted during evaluation.The break on the balloon joint most likely contributed to the leakage.However a definitive root cause for the reported material rupture, frayed material and break issue could not be determined based upon the provided 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: 12/2022), g3.H11: b3, e1, h6 (method, result and 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.

• Brand Name: DORADO 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: 10665376
• Report Number: 2020394-2020-20022
• Device Sequence Number: 11676607
• Product Code: LIT
• UDI-Device Identifier: 00801741058806
• UDI-Public: (01)00801741058806
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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: DR8068
• Device Catalogue Number: DR8068
• Device Lot Number: 93YD0158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 05/10/2021
• 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