MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number M00556581

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(initial reporter facility name): (b)(6).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a jagwire guidewire was used in a procedure performed on (b)(6) 2020.According to the complainant, during preparation, it was noted that there was a cut in the sterile device packaging and the jagwire inside looked worn.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h6 (device codes): problem code 2385 captures the reportable event of tear, rip, or hole in device packaging.E1 (initial reporter facility name): (b)(6).Block h10: visual analysis of the device revealed that the packaging box had a torn corner.The reported event was confirmed.This type of incident is likely related to improper handling, therefore, this defect could be traced to storage or transport problems due to mishandling and not a manufacture related issue.There are manufacturing and packaging processes including inspections to identify any potential failures related to the packaging box before it gets shipped out.If the inner pouch is found damage the product builder will proceed to scrap and replace it.Based on the information available and the analysis performed, the investigation conclusion code for the reported event will be documented as cause traced to transport/storage was assigned to this complaint since problems traced to the inappropriate transport or storage of the device.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu.).

Event Description

It was reported to boston scientific corporation that a jagwire guidewire was used in a procedure performed on (b)(6) 2020.According to the complainant, during preparation, it was noted that there was a cut in the sterile device packaging and the jagwire inside looked worn.No further information has been obtained despite good faith efforts.

• Brand Name: JAGWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10437151
• MDR Text Key: 203867112
• Report Number: 3005099803-2020-03492
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729339151
• UDI-Public: 08714729339151
• Combination Product (y/n): N
• PMA/PMN Number: K141820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

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: 03/26/2023
• Device Model Number: M00556581
• Device Catalogue Number: 5658
• Device Lot Number: 0025412097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1