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

Catalog Number	DR80610
Medical Device Problem Codes	Break (1069); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2018
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 when inflating a pta balloon to 22 atm, the balloon allegedly was unable to inflate to the desired pressure, not exceeding 20 atm.It was further alleged that an attempt to inflate the balloon to 12 atm was successful.Reportedly, upon removal, damage was found.There was no reported patient injury.
Additional Manufacturer Narrative
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.This is the only complaint reported to date for this lot number and failure mode.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Investigation summary: the device was returned for evaluation.The device was inflated with water, and water was seen exiting the device at the proximal balloon butt joint.The device was unable to be fully inflated.Upon closer examination, a partial break at the butt joint was identified.Therefore, the investigation is confirmed for a break at the butt joint as well as confirmed for the reported inflation issue.The partial break at the glue butt joint resulted in the inflation issue.However, the definitive root cause for the partial break could not be determined based upon available information.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 when inflating a pta balloon to 22 atm, the balloon allegedly was unable to inflate to the desired pressure, not exceeding 20 atm.It was further alleged that an attempt to inflate the balloon to 12 atm was successful.Reportedly, upon removal, damage was found.There was no reported patient injury.
Event or Problem Description
It was reported that when inflating a pta balloon to 22 atm, the balloon allegedly was unable to inflate to the desired pressure, not exceeding 20 atm.It was further alleged that an attempt to inflate the balloon to 12 atm was successful.Reportedly, upon removal, damage was found.There was no reported patient injury.
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 previously submitted emdr inadvertently left blank.The date on the emdr should have been reported as 05/14/2018.Section a through f - 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.

• 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: 7593090
• Report Number: 2020394-2018-00852
• Device Sequence Number: 18884454
• Product Code: DQY
• UDI-Device Identifier: 00801741058837
• UDI-Public: (01)00801741058837
• 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,Followup
• Report Date (Section B): 08/15/2018

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: DR80610
• Device Lot Number: 93YB0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/03/2018; 08/01/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/24/2018; 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 65