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

Model Number DR8044

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 07/22/2021

Event Type  malfunction  

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: one dorado pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device appeared bloody and no other anomalies were noted.On the functional evaluation, an in-house presto inflation device was used to inflate the balloon but was unable to be inflated or maintain pressure.The catheter shaft was then cut multiple times and attached to a touhy adapter to be inflated but was still unable to inflate.The catheter was examined under magnification, the dried blood and contrast was noted in the catheter.The circumferential break was also noted at the proximal balloon joint.No further testing was performed.Therefore the investigation for the reported leakage remains inconclusive, as the functional testing was not performed due to the contrast medium and the blood that was noted to be dried inside the inflation lumen of the returned device.The investigation for the identified circumferential break was confirmed, as the break was noted at the proximal balloon joint under the microscopic observation.A definitive root cause for the reported leakage and the identified circumferential break 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.(expiry date: 12/2023).

Event Description

It was reported that during angioplasty procedure through superficial femoral artery via cfa/popliteal, the balloon allegedly had leakage.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: one dorado pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device appeared bloody and no other anomalies were noted.On the functional evaluation, an in-house presto inflation device was used to inflate the balloon but was unable to be inflated or maintain pressure.The catheter shaft was then cut multiple times and attached to a touhy adapter to be inflated but was still unable to inflate.The catheter was examined under magnification, the dried blood and contrast was noted in the catheter.The circumferential break was also noted at the proximal balloon joint.No further testing was performed.Therefore the investigation for the reported leakage remains inconclusive, as the functional testing was not performed due to the contrast medium and the blood that was noted to be dried inside the inflation lumen of the returned device.The investigation for the identified circumferential break was confirmed, as the break was noted at the proximal balloon joint under the microscopic observation.The identified circumferential break is likely the root cause for the reported leakage.However, the definitive root cause for the reported leakage and the identified circumferential break 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: 12/2023), g3.H11: e1(initial reporter city).H11: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.H3 other text : see h10.

Event Description

It was reported that during an angioplasty procedure through superficial femoral artery via cfa/popliteal, the balloon allegedly had leakage.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
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12662812
• MDR Text Key: 277369944
• Report Number: 2020394-2021-01891
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741058301
• UDI-Public: (01)00801741058301
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K072283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DR8044
• Device Catalogue Number: DR8044
• Device Lot Number: 93ZE0067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1