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

Model Number	DR135104
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 05/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly could not be fully deflated.It was further reported that a percutaneous needle stick was used to deflate the balloon.The current patient status is unknown.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly could not be fully deflated.It was further reported that a percutaneous needle stick was used to deflate the balloon.The current patient status is unknown.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the deflation problem could not be determined based upon the provided 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.Expiry date: 05/2023 section a through f - the information provided by bd 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 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: 11430963
• Report Number: 2020394-2021-00456
• Device Sequence Number: 3243392
• Product Code: LIT
• UDI-Device Identifier: 00801741059568
• UDI-Public: (01)00801741059568
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DR135104
• Device Catalogue Number: DR135104
• Device Lot Number: 93SE0021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 05/06/2021
• 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: Required Intervention