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

Model Number	DR135610
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 05/2021).
Event or Problem Description
It was reported that prior to a pta procedure, the balloon was allegedly found to be frayed after removing the protective sleeve off the device.There was no patient contact.
Additional Manufacturer Narrative
H10: 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.Investigation summary: one dorado pta catheter was returned for evaluation.On the visual evaluation, the device have some blood residue.The balloon was still in folded position within balloon protector and balloon noted to be bunched.Circumferential break noted at the glue joint and the inner inflation lumen was exposed.No other anomalies were noted to the device.Therefore, the investigation has confirmed for material deformation balloon noted to be bunched distally on the device returned for evaluation.The investigation has confirmed for identified break as the returned device noted to have break at the proximal glue joint and the inner guide wire lumen was exposed.A definitive root cause for the material def.Ormation and identified break 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.H10: d4(expiry date: 05/2021),g3,h6(method).H11: h6(device, result and conclusion).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.H3 other text : see h10.
Event or Problem Description
It was reported that prior to a pta procedure, the balloon was allegedly found to be frayed after removing the protective sleeve off the device.The procedure was completed using another device.There was no patient contact.

• 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: 10957327
• Report Number: 2020394-2020-20761
• Device Sequence Number: 11560544
• Product Code: LIT
• UDI-Device Identifier: 00801741058851
• UDI-Public: (01)00801741058851
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/15/2021

1 Device 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: DR135610
• Device Catalogue Number: DR135610
• Device Lot Number: 93SC0052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No