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

Catalog Number ATG80182

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.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 during preparation for an angioplasty procedure the sterile packaging allegedly contained a particle inside.There was no reported patient contact.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The lot met all release criteria.Visual/microscopic inspection: as the sample was not returned for evaluation, a visual/microscopic inspection could not be performed.Functional/performance evaluation: as the sample was not returned for evaluation, a functional/performance evaluation could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation.The definitive root cause could not be determined based upon the available information.A review of previous investigations could not be performed, as there are no closed previous investigations.All previous investigations are currently ongoing.Labeling review: the current ifu (instructions for use) states: warnings: contents supplied sterile using ethylene oxide (eo).Non-pyrogenic.Do not use if sterile barrier is opened or damaged.Single patient use only.Do not reuse, reprocess, or re-sterilize.Precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape, and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.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 during preparation for an angioplasty procedure the sterile packaging allegedly contained a particle inside.There was no reported patient contact.

Manufacturer Narrative

Manufacturing review: 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.Visual/microscopic inspection: the sample was returned sealed inside the original packaging.The outer cardboard pouch was returned as well as the inner sealed sleeve.No visual defects were noted to either packaging.The user had indicated with a circle where the alleged foreign material was located.The inner packaging at the circle was examined under microscopic magnification (25x) and a small foreign material was noted.The device was sent to the manufacturing site for further evaluation.Visual inspection from manufacturing site (fmi): the sample was received in the original packaging.The open sleeve contains an unopened pouch containing the catheter.Written on the outside of the pouch states "filament".The fmi label contains the part number and lot number.The balloon side of the hub is marked 16 atm rated burst pressure and the wire side of the hub is marked.035".The foreign material was not detectable.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was returned for evaluation.The inner packaging sleeve was examined under microscopic magnification and a small filament/fiber was noted within the sealed device packaging.The unopened device was sent to the manufacturing site for further evaluation; however, the material was not able to be detected.Although the foreign material was not observed at the manufacturing site, the investigation is confirmed for foreign material.The definitive root cause for the foreign material could not be determined based upon the available information.Labeling review: the current ifu (instructions for use) states: warnings: contents supplied sterile using ethylene oxide (eo).Non-pyrogenic.Do not use if sterile barrier is opened or damaged.Single patient use only.Do not reuse, reprocess, or re-sterilize.Precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape, and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.

Event Description

It was reported that during preparation for an angioplasty procedure the sterile packaging allegedly contained a particle inside.There was no reported patient contact.

• Brand Name: ATLAS GOLD PTA BALLOON 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): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens TX 75751
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6312656
• MDR Text Key: 66863541
• Report Number: 2020394-2017-00047
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060854
• UDI-Public: (01)00801741060854(17)190531(10)93RA0225
• Combination Product (y/n): N
• Reporter Country Code: TN
• PMA/PMN Number: K122984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: ATG80182
• Device Lot Number: 93RA0225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2016
• 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