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

Model Number	AT75204
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
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.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 05/2024).
Event or Problem Description
It was reported that prior to an angioplasty procedure, the outer and inner product package was allegedly damaged.There was no patient contact.
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 sealed atlas pta dilatation catheter was received for evaluation.During visual evaluation, several bends were observed throughout the inner product packaging.Kinks and breaks were noted throughout the plastic tubing.Kinks were also noted to the catheter shaft.No anomalies were noted to the luers, bifurcate or glue fillets.Functional testing was not done due to the nature of the device.During microscopic evaluation at 20x, multiple breaks were noted on the plastic tubing.Therefore the investigation is confirmed for the alleged packaging problem as several bends were observed throughout the inner product packaging during visual evaluation.One electronic photo was reviewed.The photo shows the outside packaging of the atlas device.The packaging is noted to be bent in multiple places along its length.Therefore, based on the photo review, the alleged packaging problem can be confirmed since the packaging is noted to be bent.Additionally, multiple breaks were noted on the plastic tubing during microscopic evaluation.A definitive root cause for the alleged packaging problem 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: 05/2024), g3.H11: h6 (device, method, result, conclusion).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 or Problem Description
It was reported that prior to an angioplasty procedure, the outer and inner product package was allegedly damaged.There was no patient contact.

• Brand Name: ATLAS
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12216292
• Report Number: 2020394-2021-01384
• Device Sequence Number: 4448262
• Product Code: DQY
• UDI-Device Identifier: 00801741062520
• UDI-Public: (01)00801741062520
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: AT75204
• Device Catalogue Number: AT75204
• Device Lot Number: GFFS0374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 10/07/2021
• 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