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

Model Number	ATG80184
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
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: 06/2021).
Event or Problem Description
It was reported that post angioplasty procedure through the right common femoral vein to treat central venous stenosis of the right immoninated venous trunk, the balloon was deflated.However, when withdrawing the balloon, the device allegedly had retraction problem.It was further reported that the whole device was withdrawn with the introducer sheath and the balloon at the same time.There was no reported patient injury.
Event or Problem Description
It was reported that post angioplasty procedure through the right common femoral vein to treat central venous stenosis of the right ammoniated venous trunk, the balloon was deflated and the device allegedly had retraction problem.It was further reported that the whole device was withdrawn with the introducer sheath and the balloon at the same time.There was no reported patient injury.
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 atlas gold loaded with unknown sheath has returned for the evaluation.On the visual evaluation , the device appeared bloody and the balloon was loaded into a unknown sheath.The sheath was noted to be buckled , the balloon was bunched and prolapsed at the distal end which exposes the inner guidewire lumen.Then the sheath was retracted from the balloon and the break was noted at the balloon glue joint proximally to the catheter exposing the inner guide wire lumen.The glue bullet was noted to be pulled back and not seated properly and the marker bands was also observed not in the correct position.No functional testing was performed due to the condition of the returned sample.Under the microscopic observation, the break was noted proximal glue joint and examined.Therefore the investigation is confirmed for the reported retraction issue, as the balloon was returned stuck inside the sheath and prolapsed at the distal end.The investigation is confirmed for the identified balloon joint break, as the glue bullet was noted to be pulled back from the catheter.The reported retraction issue most likely contributed to the balloon glue joint break.A definitive root cause could not be determined based upon the available 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: 06/2021), g3, h6 (device).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.

• Brand Name: ATLAS GOLD 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: 11493725
• Report Number: 2020394-2021-00573
• Device Sequence Number: 14755298
• Product Code: DQY
• UDI-Device Identifier: 00801741060878
• UDI-Public: (01)00801741060878
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: ATG80184
• Device Catalogue Number: ATG80184
• Device Lot Number: 93TC0141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 06/29/2021
• 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: Other
• Patient Age: 57 YR
• Patient Weight: 104