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); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
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 return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 06/2023).
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, the pta balloon allegedly ruptured at 20 atm.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event investigation summary: one device was returned for evaluation.The device was noted to have kinks throughout.The guidewire lumen was able to be flushed and a in house guidewire was able to be advanced through the device with some resistance.An in house presto device was used to inflate the device and the balloon was noted to inflate and deflate without issues.The balloon was inflated a second time water was noted to be exiting from the proximal glue joint.As the water leaked the pressure gauge was noted to drop in pressure level.Under magnification a partial circumferential break was noted to the proximal glue joint.Therefore, the investigation is unconfirmed for the for the reported balloon rupture, as no rupture was noted to the balloon during evaluation.However, the investigation is confirmed for the identified break, as a partial circumferential break was noted to the proximal glue joint during evaluation.The definitive root cause 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.H10: d4 (expiry date: 06/2023),g3 h11: h6(method, result and conclusion) 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.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: 11331408
• Report Number: 2020394-2021-00264
• Device Sequence Number: 19066298
• 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): 03/10/2021

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: 93TE0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 05/27/2021
• 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
• Patient Age: 76 YR
• Patient Weight: 75