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

Model Number AT120144

Device Problems Peeled/Delaminated (1454); Retraction Problem (1536); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2018

Event Type  malfunction  

Manufacturer Narrative

No device and no medical records were provided to the manufacturer; however a photo of the sample was provided and is currently being investigated.The lot number for the device was provided.The device history records are currently under review.The investigation of the reported event is currently underway.The information provided by bard 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 bard.

Event Description

It was reported that after a angioplasty procedure in the left iliac vein, the pta balloon fibers were found to be allegedly unraveled and peeling off of the balloon.It was further reported that there was difficulty retracting the balloon through the sheath.There was no reported patient injury.

Manufacturer Narrative

The device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.The device was not returned, however one electronic photo was provided for review.Based on the photo review, the investigation is confirmed for peeling of the outer pebax.However, the investigation is inconclusive for the reported unraveled balloon fibers and retraction issue, as the photo review could not confirm the reported issues, and as the sample was not returned for full visual and functional evaluation of the device.The definitive root cause for the identified peeled pebax or reported fiber and retraction issues could not be determined based upon available information.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date-07/2020).

Event Description

It was reported that after a angioplasty procedure in the left iliac vein, the pta balloon fibers were found to be allegedly unraveled and peeling off of the balloon.It was further reported that there was difficulty retracting the balloon through the sheath.There was no reported patient injury.

• Brand Name: ATLAS 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): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7447442
• MDR Text Key: 106271370
• Report Number: 2020394-2018-00420
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741062636
• UDI-Public: (01)00801741062636
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K120971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: AT120144
• Device Catalogue Number: AT120144
• Device Lot Number: GFBU1447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2017
• 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