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

Catalog Number	DR8086
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during an angioplasty procedure in an arm fistula, the pta balloon had difficulty retraction through the sheath.Another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
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.This is the only complaint reported to date for this lot number and failure mode.The device was returned for evaluation.A visual inspection found a complete break to the butt joint between the catheter shaft and the proximal portion of the balloon; the inner guidewire lumen was still intact.Additionally, the balloon was returned lodged in an introducer sheath with signs of retraction issues (e.G.Bunched balloon material, flared introducer sheath tip).Therefore, the investigation is confirmed for both a break at the butt joint as well as for sheath-related retraction issues.It is likely that the retraction issues led to the catheter break at the butt joint.However, the definitive root cause for the retraction issues could not be determined based upon the available information.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that during an angioplasty procedure in an arm fistula, the pta balloon had difficulty retracting through the sheath.Another device was used to complete the procedure.There was no reported patient injury.

• 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: 7809820
• Report Number: 2020394-2018-01537
• Device Sequence Number: 1293449
• Product Code: DQY
• UDI-Device Identifier: 00801741059292
• UDI-Public: (01)00801741059292
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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 Catalogue Number: DR8086
• Device Lot Number: 93SB0099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1