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

Model Number	M001468060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the distal tip of the subject guidewire broke while inserting the guidewire into the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure the distal tip of the subject guidewire broke while inserting the guidewire into the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Section b1 adverse event/product problem - corrected - no product problem.Section h1 type of reportable event - corrected - no malfunction.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D9 product available to stryker- updated.D9 returned to manufacturer on- updated.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 visual inspection, the guidewire was seen to be broken/fractured 92.6cm from the proximal end.The proximal fracture of the guidewire was seen to be kinked/bent 78cm from the proximal end.The distal fracture of the guidewire was seen to be kinked/bent 1cm from the proximal end.The guidewire tip was intact.A functional inspection was not required.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.Additional information provided by the customer indicated that there were no anomalies noted to the device during initial inspection and preparation, the device was prepared as per the dfu, the dispenser hoop was flushed and there was no resistance encountered when removing the guidewire from the dispenser hoop, the guidewire tip was shaped 30 degrees, and the issue occurred during preparation outside the patient's body.During the visual inspection, the returned guidewire was found to be broken/fractured 92.6cm from the proximal end, confirming the reported event.The proximal fractured segment was noted to be kinked/bent 78cm from its proximal end and the distal fractured segment was noted to be kinked/bent 1cm from its proximal end.An assignable cause of handling damage will be assigned to the reported and analyzed defect guidewire broken/fractured during preparation as well as the analyzed defect guidewire kinked/bent since the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.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 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
• Manufacturer (Section G): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CS 20101
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 16326789
• Report Number: 3008853977-2023-00003
• Device Sequence Number: 12965118
• Product Code: DQX
• UDI-Device Identifier: 08714729201212
• UDI-Public: 08714729201212
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 05/16/2023

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: 09/23/2023
• Device Model Number: M001468060
• Device Catalogue Number: M001468060
• Device Lot Number: 28076507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TREVO PRO 18 MICROCATHETER (STRYKER)
• Patient Age: 52 YR
• Patient Sex: Female