MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRATOME XL; SNARE, FLEXIBLE

Model Number M00535920

Device Problems Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an ultratome xl was received from the distribution center.According to the complainant, upon receipt of the ultratome xl from the distribution center, it was found dirty.There was no procedure involved and the device was not used in the patient.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that an ultratome xl was received from the distribution center.According to the complainant, upon receipt of the ultratome xl from the distribution center, it was found dirty.There was no procedure involved and the device was not used in the patient.Additional information regarding the circumstances surrounding this event was received, which clarified that the spot was located outside the packaging of the device.Reportedly, there was no damage noted on the packaging and it was confirmed that the sterile barrier was not compromised.

Manufacturer Narrative

(date of event): the exact date of the event is unknown.The provided event date 01apr2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(device codes): problem code updated to 2969, which captures the non-reportable event of foreign matter on packaging.Additional information clarified that the sterile barrier was not compromised, and the reported spot described as "dirty" was found outside the packaging.(evaluation conclusion codes): although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Manufacturer Narrative

Block b3 (date of event): the exact date of the event is unknown.The provided event date 01apr2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6 (device codes): problem code 2969 captures the non-reportable event of foreign matter on packaging.Additional information clarified that the sterile barrier was not compromised, and the reported spot described as "dirty" was found outside the packaging.Block h10: visual examination of the returned unit revealed that the device was returned its original unopened pouch, and the pouch was found dirty in several locations.It is most likely that this issue was caused during manipulation of the device or due to the interaction with the shipping process.Therefore, the most probable cause of this complaint is cause traced to transport/storage, the adverse event occurred during shipping process and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that an ultratome xl was received from the distribution center.According to the complainant, upon receipt of the ultratome xl from the distribution center, it was found dirty.There was no procedure involved and the device was not used in the patient.Additional information regarding the circumstances surrounding this event was received, which clarified that the spot was located outside the packaging of the device.Reportedly, there was no damage noted on the packaging and it was confirmed that the sterile barrier was not compromised.

• Brand Name: ULTRATOME XL
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8582952
• MDR Text Key: 144158862
• Report Number: 3005099803-2019-02389
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: 08714729103318
• Combination Product (y/n): N
• PMA/PMN Number: K930022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2019

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 Expiration Date: 12/15/2020
• Device Model Number: M00535920
• Device Catalogue Number: 3592
• Device Lot Number: 0023090073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 05/27/2019; 06/26/2019
• Supplement Dates FDA Received: 06/20/2019; 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1