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

Model Number DR80810

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 08/02/2021

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.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2024).

Event Description

It was further reported that during an angioplasty procedure, the pta balloon allegedly had difficulty in removing from the sheath.It was further reported that the balloon was pulled along with the sheath.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: two photos were reviewed.The first photo shows that the balloon was stuck inside an unknown introducer sheath and appeared to be detached.The distal end of the balloon was noted to be prolapsed over the distal tip while inserted in the introducer sheath.Balloon and the sheath was noted to be bloody and no other anomalies were noted.The second photo shows the catheter shaft appeared to be separated from the balloon which exposes the inner guide wire lumen.The catheter shaft appeared to be clean and no other anomalies were noted.Therefore based on the photo review, the reported difficult to remove and detachment of balloon was confirmed as the balloon stuck inside the sheath and got detached from the catheter during the withdrawal.One dorado pta dilatation catheter received in two segments for the evaluation.On the visual evaluation, the first segment consists of detached balloon stuck into an unknown introducer sheath.The distal end of the balloon was noted to be prolapsed over the distal tip while inserted in the introducer sheath.The second segment consists of the catheter, luers and bifurcate or glue fillets, which exposes the inflation and the guidewire lumen.No other specific anomalies were noted.Under x-ray imaging and microscopic observation, the balloon stuck into unknown 6f sheath was examined and noted that the two marker bands were present proximal and distal.On the functional evaluation, the introduce sheath was cut to removed the balloon.Additionally, the balloon was cut and noted distal marker band attached to the guidewire lumen and proximal marker band was not seated in its original place.Therefore the investigation for the reported difficult to remove was confirmed as the balloon returned was stuck inside the introducer sheath.The investigation for the identified detachment of the balloon was confirmed as the device was returned in two segments for the evaluation.The reported difficult to remove is the likely cause of the identified balloon detachment.However, the definitive root cause for the reported difficult to remove and the identified detachment of the balloon could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 06/2024),.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly had difficulty in removing from the sheath.It was further reported that the balloon was pulled along with the sheath.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: DORADO
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12408114
• MDR Text Key: 271899568
• Report Number: 2020394-2021-01555
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741059360
• UDI-Public: (01)00801741059360
• 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: 09/08/2021

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: DR80810
• Device Catalogue Number: DR80810
• Device Lot Number: 93SF0131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/20/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 54