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

Model Number	DR80510
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
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.The investigation of the reported event is currently underway.Expiry date: 07/2023.
Event or Problem Description
It was reported that prior to an angioplasty procedure via ipsilateral antegrade approach, the pta balloon allegedly failed to inflate and leaked.It was further reported that another device was used to complete the procedure.There was no patient contact.
Event or Problem Description
It was reported that prior to an angioplasty procedure via ipisilateral antegrade approach, the pta balloon allegedly failed to inflate and leaked.It was further reported that another device was used to complete the procedure.There was no patient contact.
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 able to be flushed and inserted with an in-house guidewire without any issues.The balloon was then inflated using an in house presto device to nominal pressure and water was noted to be leaking from the proximal end of the balloon.The balloon fibers were removed and a partial circumferential break was noted to the proximal glue joint.Therefore, the investigation is confirmed for the reported inflation issue, as the device could not be inflated to nominal pressure during evaluation.The investigation is also confirmed for the reported leak and glue joint break as a partial circumferential break was noted to the catheter balloon glue joint break during evaluation.The glue joint break noted during evaluation most likely contributed to the leakage noted.The leakage noted most likely contributed to the reported inflation issue.The definitive root cause for the reported inflation issue and the identified leakage and break could not be determined.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 07/2023), g3, h6(method) 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.

• 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: 11875924
• Report Number: 2020394-2021-01105
• Device Sequence Number: 16976329
• Product Code: LIT
• UDI-Device Identifier: 00801741058578
• UDI-Public: (01)00801741058578
• 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): 08/06/2021

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: DR80510
• Device Catalogue Number: DR80510
• Device Lot Number: 93TE0107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 08/06/2021
• 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