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

Model Number	DR8054
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record 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: 12/2022).
Event or Problem Description
It was reported that during an angioplasty procedure of a calcified lesion in the subclavian vein, the pta balloon allegedly ruptured at nominal pressure.The lesion was mildly calcified.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure of a calcified lesion in the subclavian vein, the pta balloon allegedly ruptured at nominal pressure.The lesion was mildly calcified.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 catheters was returned for evaluation.A visual inspection was performed and device appeared to be bloody.No other anomalies were noted to the device.An in house presto inflation device was used to inflate the device, and a leak was noted to the proximal end of the balloon.A circumferential glue joint break was noted to the proximal end of the balloon under magnification.No other functional test performed, due to condition of the device.Therefore, the investigation is confirmed for the identified glue joint break, as a glue joint break was noted during microscopic evaluation.The investigation is also confirmed for the identified leak issue, as water was noted to be leaking from the proximal balloon joint during functional testing.The investigation is inconclusive for the reported balloon rupture, as functional test could not performed due to condition of the device.The glue joint break noted is the likely cause of the leak.However, the definitive root cause for the reported balloon rupture, identified glue joint break and leak 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.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.H3 other text : see h10.

• 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: 11106475
• Report Number: 2020394-2020-21007
• Device Sequence Number: 3922961
• Product Code: LIT
• UDI-Device Identifier: 00801741058493
• UDI-Public: (01)00801741058493
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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: DR8054
• Device Catalogue Number: DR8054
• Device Lot Number: 93ZD0127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 04/20/2021
• 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