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

Catalog Number	DR80810
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.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 for evaluation.The investigation of the reported event is currently underway.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 a pta balloon catheter would not fully withdraw through the sheath.The balloon become stuck in the sheath and necessitated removal of both the balloon and sheath together.It was further alleged that the balloon detached upon removing the balloon and sheath.Reportedly, the health care provider used a larger balloon catheter and sheath to continue the procedure.The patient was reported as doing fine post procedure.
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 the device returned stuck in the users introducer sheath.The distal end of the sheath was flared, and the balloon material was prolapsed over the distal tip.Therefore, the investigation is confirmed for the reported retraction issues.Additionally, a complete break at the proximal balloon butt joint was identified; the inner guidewire lumen was intact.Therefore, the investigation is confirmed for a break.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.(b)(4).
Event or Problem Description
It was reported that a pta balloon catheter would not fully withdraw through the sheath.The balloon become stuck in the sheath and necessitated removal of both the balloon and sheath together.It was further alleged that the balloon detached upon removing the balloon and sheath.Reportedly, the health care provider used a larger balloon catheter and sheath to continue the procedure.The patient was reported as doing fine post procedure.

• Brand Name: DORADO PTA BALLOON 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: 7442068
• Report Number: 2020394-2018-00408
• Device Sequence Number: 1146561
• Product Code: DQY
• UDI-Device Identifier: 00801741059360
• UDI-Public: (01)00801741059360
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: DR80810
• Device Lot Number: 93NC0189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 137