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	06/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intracranial aneurysm embolization in a patient, the subject guidewire broke into 2 parts.Balloon was removed with distal portion of fractured subject guidewire.There was a surgical delay of 5 min due to the event.The procedure was completed successfully by replacing the subject device and no clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during intracranial aneurysm embolization in a patient, the subject guidewire broke into 2 parts.Balloon was removed with distal portion of fractured subject guidewire.There was a surgical delay of 5 min due to the event.The procedure was completed successfully by replacing the subject device and no clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.Based on the results of the device history record (dhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The device was received.The reported lot number was confirmed from the packaging label.During visual/ microscopic inspection, the guidewire was noted to be severely kinked/bent.The guidewire distal tip was noted to be kinked/bent.The guidewire was returned broken/fractured in 2 segments (71.3cm distal segment and 110.5cm proximal segment).Functional inspection was not required.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.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.Additional information provided by the customer indicated that no abnormalities were noted on the device during initial inspection and preparation, the device was prepared according to the ifu, continuous flush was maintained throughout the procedure, moderate friction/resistance was encountered during the procedure, and no force was used to overcome the resistance.During analysis, the guidewire was noted to be severely kinked/bent along its working length and also at its distal end/tip.The guidewire was returned broken/fractured in 2 segments (71.3cm distal segment and 110.5cm proximal segment).Therefore, the reported event was confirmed.Based on analysis, it is possible that the guidewire may have encountered some tension or torsion forces during use that caused the device to kink and then fracture.An assignable cause of procedural factors will be assigned to the as reported and as analyzed event of guidewire broken/fractured during use as well as the as analyzed events of guidewire kinked/bent and guidewire distal end/tip kinked/bent since these issues are 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 and/or anatomical factors during use.

• 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
• 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: 14983284
• Report Number: 3008853977-2022-00037
• Device Sequence Number: 14695831
• Product Code: DQX
• UDI-Device Identifier: 08714729187332
• UDI-Public: 08714729187332
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K971254
• 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): 09/27/2022

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: 08/10/2023
• Device Model Number: M001468050
• Device Catalogue Number: M001468050
• Device Lot Number: 27812148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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: BALLOON (UNKNOWN); BALLOON (UNKNOWN)
• Patient Sex: Unknown