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

Catalog Number	AT120164
Medical Device Problem Codes	Material Frayed (1262); Peeled/Delaminated (1454); Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem Description
It was reported that during an angioplasty procedure in the left external iliac vein via left popliteal vein, the pta balloon allegedly had some resistance upon removal.There was no reported patient injury.
Additional 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.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 or Problem 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.
Additional 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
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 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
• Report Number: 2020394-2023-01337
• Device Sequence Number: 8145603
• Product Code: DQY
• UDI-Device Identifier: 00801741062667
• UDI-Public: (01)00801741062667(11)221214(17)251128(10)GFGY1576
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K120971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2025
• Device Catalogue Number: AT120164
• Device Lot Number: GFGY1576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 04/03/2024; 06/12/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 04/06/2024; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: White