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

Model Number M00556581

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

(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 a jagwire was used in a procedure on (b)(6) 2020.According to the complainant, during the procedure, an endoscopic scope and jagwire guidewire were inserted into the patient.The jagwire was fed through non boston scientific sheath and into the handle.Sheath connected to handle and screwed into place.Wire tightened in order to advance to upper gi.During the retrieval of the wire and scope from the stomach, anesthetist noticed patient hemorrhaging from mouth.Boston scientific has been unable to obtain additional information regarding the event to date.

Event Description

It was reported to boston scientific corporation that a jagwire was used in a procedure on (b)(6) 2020.According to the complainant, during the procedure, an endoscopic scope and jagwire guidewire were inserted into the patient.The jagwire was fed through non boston scientific sheath and into the handle.Sheath connected to handle and screwed into place.Wire tightened in order to advance to upper gi.During the retrieval of the wire and scope from the stomach, anesthetist noticed patient hemorrhaging from mouth.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information received on november 04, 2020: problem was noticed when the guidewire was in position and doctor was threading the mechanical lithotripsy sheath on the wire.The doctor had the gastroscope in the esophagus awaiting for the lithocrush to arrive.Patient was under general anesthetic.The planned procedure was halted; emergency ent (ear, nose, and throat) and gi (gastrointestinal) surgical consultations occurred, emergency bleeding and wound management (mouth/base of tongue) was carried out.The planned procedure was completed following which the patient was admitted to icu (intensive care unit) under sedation.Patient obesity with a large tongue was reported as one of the co-morbidities that possibly lead to the event.Reportedly in the physician's assessment in part the device malfunction contributed to hemorrhaging from mouth.The procedure was completed with different manufacturer's devices.The procedure name is dissection and removal of intra-gastric lap band and a non-boston scientific lithotripsy was used.

Manufacturer Narrative

Block h6 (device codes): problem code 2588 captures the reportable event of jagwire malfunction contributed to patient hemorrhaging.Block h6 (patient codes): patient code 1932 captures the reportable event of patient hemorrhaging from mouth.H10: visual analysis of the device revealed that jagwire guidewire was damaged, the core wire was fractured in four different sections and were highly kinked.The fractured sections of the wire shows evidence of mechanical cut and bending.In addition, ptfe was peeled exposing the corewire.The pebax section was not returned for analysis.The evidence of mechanical cut demonstrates that the device was cut with some sharp tool generating the bending which could have happened due to the application of excessive force.The ptfe was peeled exposing the core wire and was highly kinked.It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Handling and manipulation of the device during procedure and interaction with non-boston scientific lithotripsy could have caused damages/deformities on the device.Forcing the device against significant resistance could result in device damage or loss of functionality.It is important to highlight that the event description states "patient obesity with a large tongue was reported as one of the co-morbidities that possibly lead to the event", hence, this patient condition could have limited the device performance during procedure.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.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 instructions for use (ifu)/product label.

Manufacturer Narrative

Block h6 (device codes): problem code 2588 captures the reportable event of jagwire malfunction contribute to patient hemorrhaging.Block h6 (patient codes): patient code 1932 captures the reportable event of patient hemorrhaging from mouth.Block h6 (evaluation conclusion codes): 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.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.

Event Description

It was reported to boston scientific corporation that a jagwire was used in a procedure on (b)(6) 2020.According to the complainant, during the procedure, an endoscopic scope and jagwire guidewire were inserted into the patient.The jagwire was fed through non boston scientific sheath and into the handle.Sheath connected to handle and screwed into place.Wire tightened in order to advance to upper gi.During the retrieval of the wire and scope from the stomach, anesthetist noticed patient hemorrhaging from mouth.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information received on november 04, 2020: problem was noticed when the guidewire was in position and doctor was threading the mechanical lithotripsy sheath on the wire.The doctor had the gastroscope in the esophagus awaiting for the lithocrush to arrive.Patient was under general anesthetic.The planned procedure was halted; emergency ent (ear, nose, and throat) and gi (gastrointestinal) surgical consultations occurred, emergency bleeding and wound management (mouth/base of tongue) was carried out.The planned procedure was completed following which the patient was admitted to icu (intensive care unit) under sedation.Patient obesity with a large tongue was reported as one of the co-morbidities that possibly lead to the event.Reportedly in the physician's assessment in part the device malfunction contributed to hemorrhaging from mouth.The procedure was completed with different manufacturer's devices.The procedure name is dissection and removal of intra-gastric lap band and a non-boston scientific lithotripsy was used.

• 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: 10542208
• MDR Text Key: 207221721
• Report Number: 3005099803-2020-03844
• 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,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2022
• Device Model Number: M00556581
• Device Catalogue Number: 5658
• Device Lot Number: 0024198387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 11/04/2020; 12/23/2020
• Supplement Dates FDA Received: 11/17/2020; 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other