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

Catalog Number AT120164

Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Difficult to Remove (1528); Unraveled Material (1664)

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

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

H10: 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.H10: d4 (expiry date: 11/2025) h11: section a through f ¿ the information provided 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.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly had some resistance upon removal.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure in the left external iliac vein via the left popliteal vein, the pta balloon allegedly had some resistance upon removal.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 atlas pta dilatation catheter was returned for evaluation.Frayed fiber, unraveled fiber and peeled pebax were observed on the returned balloon during the visual evaluation.On the functional testing, an in-house guide wire was able to be inserted into the catheter.However, the functional testing for sheath removal difficulties couldn¿t be performed as the in-house sheath was unable to insert due to the device condition.During the visual evaluation, frayed fiber, unraveled fiber and peeled pebax were observed on the returned catheter.However, as per the reported event, the observed fiber anomalies might be caused due to the balloon stuck within the stent at the time of procedure.Therefore, the investigation is confirmed for the identified frayed fiber, unraveled fiber and peeled pebax.However, the investigation remains inconclusive for the reported sheath removal difficulties as the functional testing couldn¿t be performed due to the device's condition.A definitive root cause for the reported sheath removal difficulties and identified frayed fiber, unraveled fiber and peeled pebax could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiration date: 11/2025), g3, h6 (device).H11: h6 (method, result, conclusion).H11: section a through f ¿ the information provided 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
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18416988
• MDR Text Key: 331600063
• Report Number: 2020394-2023-01337
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062667
• UDI-Public: (01)00801741062667
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

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 Catalogue Number: AT120164
• Device Lot Number: GFGY1576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/06/2024
• 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
• Patient Age: 96 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: White