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

Model Number	M003468150
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, resistance was encountered when advancing the subject guidewire through the microcatheter shaft and the physician noted that the guidewire tip coating was missing and uneven.Another guidewire was used to complete the procedure.There were no clinical consequences reported to the patient due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.During visual inspection, the guidewire was noted to be kinked/bent and deformed/stretched near the distal end.Also, the guidewire polytetrafluoroethylene (ptfe) coating was found peeling near the distal end confirming the reported issue.In case of this complaint, it is most likely that the tip of the guidewire and ptfe coating got damaged by the user while shaping the tip during preparation, leading to the reported friction.Because of this complaint appears to be associated with handling of the product or portion of the product during preparation of the product prior to use, a probable cause of handling damage was assigned to the as reported and as analyzed issue guidewire ptfe coating peeling.
Event or Problem Description
It was reported that during the procedure, resistance was encountered when advancing the subject guidewire through the microcatheter shaft and the physician noted that the guidewire tip coating was missing and uneven.Another guidewire was used to complete the procedure.There were no clinical consequences reported to the patient due 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 ; CR 20101
• MDR Report Key: 9470288
• Report Number: 3008853977-2019-00072
• Device Sequence Number: 11221353
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: 08714729441748
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 01/22/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2020
• Device Model Number: M003468150
• Device Catalogue Number: M003468150
• Device Lot Number: 22446734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/22/2020
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER).
• Patient Age: 68 YR
• Patient Weight: 75