MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND .014 FLOPPY 300 CM ( IC 300 ); WIRE, GUIDE, CATHETER

Catalog Number	M003468150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Embolus (1830); Visual Disturbances (2140)
Date of Event	06/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the subject guidewire was advanced to the site to perform percutaneous transluminal angioplasty (pta), and approximately about 3cm from the tip of the guidewire was broken.The broken part of the guidewire was removed with a snare device.The patient¿s anatomy was reported to be very tortuous.The procedure was stopped since the physician did not have additional guidewire.The patient had experienced a visual field deficit on the right eye the day after the procedure.The symptom was slowly improved.The physician thinks that the cause of this event was embolus of retinal artery by embolus from the right eye artery.
Event or Problem Description
It was reported that during the procedure, the subject guidewire was advanced to the site to perform percutaneous transluminal angioplasty (pta), and approximately about 3cm from the tip of the guidewire was broken.The broken part of the guidewire was removed with a snare device.The patient¿s anatomy was reported to be very tortuous.The procedure was stopped since the physician did not have additional guidewire.The patient had experienced a visual field deficit on the right eye the day after the procedure.The symptom was slowly improved.The physician think that the cause of this event was embolus of retinal artery by embolus from the right eye artery.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, only the proximal of the guidewire was received.The guidewire was separated approximately 2.5 cm from its distal end.The guidewire distal separated segment was not received.Magnified examination of the fracture site showed the core wire and polysleeve were fractured.The guidewire was found bent just proximal to the fracture site.The guidewire was bent at approximately 4.0cm from distal fractured end.From the condition of the fracture, it appears that the guidewire separated due to excessive manipulation and torsion.The guidewire polytetrafluoroethylene (ptfe) coating was scraped at approximately 150.0cm from proximal end.The guidewire was bent along its ptfe length.Functional testing was not performed due to the anomalies noted to the device.In case of this complaint, the device was prepared as per direction for use (dfu).Additionally, it was confirmed by the customer that the patient¿s anatomy was very tortuous.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use; therefore, procedural factor was assigned to the as reported and as analyzed issue guidewire distal end broken.Since the torque device was not returned with the guidewire, it could not be determined whether this contributed to the peeling of the ptfe coating; therefore, a probable cause of undeterminable was assigned to the analyzed issue guidewire ptfe coating peeling.The reported issues patient complications and patient embolus is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore; a probable cause of procedural factor was assigned to this event.

• Brand Name: TRANSEND .014 FLOPPY 300 CM ( IC 300 )
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101
• MDR Report Key: 8760781
• Report Number: 3008853977-2019-00055
• Device Sequence Number: 14084220
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: 08714729441748
• Combination Product (Y/N): N
• PMA/510(K) Number: K022357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2020
• Device Catalogue Number: M003468150
• Device Lot Number: 22326633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MARKSMAN MICROCTHETER (MEDTRONIC); MARKSMAN MICROCTHETER (MEDTRONIC)
• Outcome Attributed to Adverse Event: Other; Required Intervention