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

Model Number DR80104

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

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.(expiry date: 01/2024).

Event Description

It was reported that during an angioplasty procedure, the device balloon allegedly broke off in the sheath.It was further reported that the balloon allegedly stuck in the sheath.There was no reported patient injury.

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 dilatation catheter has returned for evaluation.On the visual evaluation the device, returned in two segments, the first segment consisting of the luers, bifurcate, partial catheter which detached at the proximal glue joint exposing the inner guidewire lumen inflation lumens.The second segment consist of remaining balloon loaded with the sheath.The distal end of the balloon was extending out of the distal end of the sheath.Then the balloon was removed from the sheath.X-ray was performed and shows both marker bands were present within the balloon.All the anomalies noted has observed in the microscopic evaluation.No further functional evaluation performed.Therefore, the investigation has confirmed reported detachment of device as the device has returned in two segments for evaluation.The investigation has also confirmed for the reported for the retraction issue as the balloon was noted to be stuck within the sheath on returning for evaluation.A definitive root cause 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: 01/2024).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 Description

It was reported that during an angioplasty procedure, the device balloon allegedly broke off in the sheath.It was further reported that the balloon allegedly stuck in the sheath.There was no reported patient injury.

• Brand Name: DORADO PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11775715
• MDR Text Key: 249082376
• Report Number: 2020394-2021-00972
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741059544
• UDI-Public: (01)00801741059544
• Combination Product (y/n): N
• PMA/PMN Number: K072283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

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
• Device Operator: Health Professional
• Device Model Number: DR80104
• Device Catalogue Number: DR80104
• Device Lot Number: 93NF0070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR