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

Model Number	M00556591
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual examination of the returned device revealed that the coil broken at 120.0 cm from the distal end.The broken section was inspected under magnification and mechanical marks were noted.It was also found on the returned device that the ptfe was peeled.The device was also kinked 62.0 cm from the proximal end.It was found during the investigation of the returned guidewire that the coil was broken.It is most likely that during procedure the device could have been manipulated, since the failures found is an issue that could have been generated by excessive manipulation of the device.Also, interaction with other devices might have impacted the integrity of the device during the procedure.Additionally, during the manufacturing process the units are inspected in order to avoid the failures reported.However, there is no control in how devices are handled in the field.All compiled information on this investigation determines that the most probable cause is adverse event related to procedure.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted device met all manufacturing specifications.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire guidewire was used in the colon sd part during a colon stent placement procedure performed on (b)(6) 2018.This device was used for a replacement of an ileus tube being placed for a patient with multiple sclerosis.According to the complainant, during the procedure, the jagwire guidewire was inserted into the lumen of the ileus tube.While the guidewire was in place, the ileus tube was removed.The endoscope was backloaded over the guidewire and advanced to the target area. an attempt was made to backload the  wallflex colonic stent over the guidewire and into the scope however, the jacket accordion and was unable to be removed.  upon removal of both devices it was noted the ptfe coating peeled.A new jagwire guidewire and wallflex colonic stent were used to complete the procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; broken coil.

• Brand Name: JAGWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8307487
• Report Number: 3005099803-2019-00435
• Device Sequence Number: 1064480
• Product Code: OCY
• UDI-Device Identifier: 08714729501398
• UDI-Public: 08714729501398
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2021
• Device Model Number: M00556591
• Device Catalogue Number: 5659
• Device Lot Number: 0022147177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1