MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 14 SOFT 205CM; WIRE, GUIDE, CATHETER

Model Number	M001468060
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure a foreign material was found due to the ptfe (polytetrafluoroethylene) of the subject guidewire peeling when inserted and removed from the microcatheter.The foreign material was removed, and the procedure was completed successfully.There were no clinical consequences to the patient reported as a result of this event.
Event or Problem Description
It was reported that during the procedure a foreign material was found due to the ptfe (polytetrafluoroethylene) of the subject guidewire peeling when inserted and removed from the microcatheter.The foreign material was removed, and the procedure was completed successfully.There were no clinical consequences to the patient reported as a result of this event.
Additional Manufacturer Narrative
D4 expiration date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.H4 manufacturing date ¿ added.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, the tip of the guidewire was noted to have been shaped.The guidewire distal section and hydrophilic coating was examined along its length.The coating was present on the guidewire but was rough.The guidewire ptfe coating was examined under magnification and the coating was noted to be damaged which is evident of damage from torque device.During functional testing, the returned guidewire was kept hydrated as per the device directions for use (dfu) and guidewire was also loaded through the demonstration sl-10 microcatheter due to the damage noted to the device.The reported event is covered in the 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.Additional information indicates there was no damage noted to the packaging prior to opening the packaging, the device was prepared for use as per the direction for use, continuous flush was maintained throughout the clinical procedure and the patient¿s anatomy was normal.Analysis of the returned device found the guidewire coating was damaged at the proximal end which would have contributed to the reported event.The as reported defects device foreign matter, guidewire ptfe coating peeling and to analyzed defects guidewire ptfe coating peeling and guidewire hydrophilic coating surface rough were assigned procedural factors as these defects appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.

• Brand Name: TRANSEND EX 14 SOFT 205CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CS 20101
• MDR Report Key: 11721647
• Report Number: 3008853977-2021-00017
• Device Sequence Number: 11590484
• Product Code: DQX
• UDI-Device Identifier: 08714729201212
• UDI-Public: 08714729201212
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K931584
• 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): 08/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2022
• Device Model Number: M001468060
• Device Catalogue Number: M001468060
• Device Lot Number: 25042147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 04/24/2021
• Supplement Report FDA Received Date: 08/23/2021
• 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: ECHELON ST MICROCATHETER (TELEFLEX MEDICAL)