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

Model Number M00556611

Device Problems Break (1069); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2021 as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a jagwire was used in a procedure.The procedure date is unknown.During preparation, the guidewire corewire tip was broken.The procedure was completed with a new jagwire.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a jagwire was used in a procedure.The procedure date is unknown.During preparation, the guidewire corewire tip was broken.The procedure was completed with a new jagwire.There were no patient complications reported as a result of this event.Additional information received on june 7, 2021: during preparation when the coating on the tip was activated using saline before inserting into patient, the physician noticed the guidewire tip was kinked/bent.

Manufacturer Narrative

Block b3 (date of event): date of event was approximated to (b)(6) 2021 as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h10: 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 medwatch will be filed.Conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned.".

Manufacturer Narrative

Block b3 (date of event): date of event was approximated to (b)(6) 2021 as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h10: a jagwire guidewire was returned.Visual analysis revealed that the distal tip section was bent.The ptfe area was kinked and has indentation marks.The complaint was not confirmed.Based on the condition of the returned device, engineers determined that the failure mode has been generated by the manipulation of the device.In addition, the indentation marks could have been generated during the process.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on the event which led to the reported event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a jagwire was used in a procedure.The procedure date is unknown.During preparation, the guidewire corewire tip was broken.The procedure was completed with a new jagwire.There were no patient complications reported as a result of this event.Additional information received on june 7, 2021: during preparation when the coating on the tip was activated using saline before inserting into patient, the physician noticed the guidewire tip was kinked/bent.

• 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: 11895197
• MDR Text Key: 252974296
• Report Number: 3005099803-2021-02527
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729172161
• UDI-Public: 08714729172161
• 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,Followup
• Report Date: 08/06/2021

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
• Device Operator: Health Professional
• Device Model Number: M00556611
• Device Catalogue Number: 5661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 06/07/2021; 07/16/2021
• Supplement Dates FDA Received: 06/24/2021; 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1