MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 14 182CM; WIRE, GUIDE, CATHETER

Model Number	M001468050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject device guidewire was completely detached from the rest of the wire while loading into the microcatheter system.The detached tip was safely removed from the patient.The physician replaced it with a different wire, and completed the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that the subject device guidewire was completely detached from the rest of the wire while loading into the microcatheter system.The detached tip was safely removed from the patient.The physician replaced it with a different wire and completed the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Section b1 product problem: corrected - remove product problem.Section h1 type of reportable event: corrected - remove malfunction.Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During analysis, the returned device was visually inspected and no anomaly was noted.The entire length of the guidewire was intact and there was no indication of a break present.It was also noted an unknown device measuring 3cm, which was not a stryker product was also returned with the subject guidewire.It is probable this unknown device was attached to the subject guidewire during preparation and detached as outlined in the event description during loading into the microcatheter.Additional questions were asked regarding this unknown device, but no response has been received to date.A functional test was performed, and the subject guidewire was inserted through a demonstration sl-10 microcatheter and advanced through the distal tip without friction.Additional information provided by the customer indicated that there was no allegation against the microcatheter and the physician thinks the microcatheter performed as intended.The detached tip was safely removed from the patient and different wires were used to complete the procedure.Based on analysis of the returned subject guidewire, the as reported ' guidewire distal tip broken/fractured during use' was not confirmed as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TRANSEND EX 14 182CM
• 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: 10898607
• Report Number: 3008853977-2020-00035
• Device Sequence Number: 19166608
• Product Code: DQX
• UDI-Device Identifier: 08714729187332
• UDI-Public: 08714729187332
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K934122
• 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): 01/12/2021

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: 07/31/2021
• Device Model Number: M001468050
• Device Catalogue Number: M001468050
• Device Lot Number: 24203600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/13/2021
• 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: MICROCATHETER (UNKNOWN MANFACTURER)