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

Catalog Number	M001468070
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not availabel to the manufacturer.
Event or Problem Description
It was reported that during one middle cerebral artery mca stenosis case, when using subject guidewire to build access, friction was encountered when advancing the subject guidewire into microcatheter.Withdrew the guidewire and found coating of the tip was peeled off.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during one middle cerebral artery mca stenosis case, when using subject guidewire to build access, friction was encountered when advancing the subject guidewire into microcatheter.Withdrew the guidewire and found coating of the tip was peeled off.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
B1 adverse event/product problem - corrected - no product problem.H1 type of reportable event - corrected - no malfunction.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.During visual/microscopic inspection, the guidewire tip was seen to be kinked/bent to the distal end.The hydrophilic coating to the guidewire tip was seen to have been used/hydrated, however no damage noted.No other anomalies were noted.There were no anomalies/peeling noted to either the distal hydrophilic coating or the proximal ptfe coating.During functional inspection, the guidewire coating was hydrated; no anomalies were noted.The guidewire was advanced through a demonstration microcatheter without difficulties.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 could not be confirmed based on analysis.The returned device failed to meet specifications when received for complaint investigation, based on the damage noted.It was reported that when using subject guidewire to build access friction was encountered when advancing the guidewire into microcatheter.Withdrew the guidewire and found tip of coating was peeled off.The device was received and the there was no visual damage noted to the coatings, the wire was able to be advanced through a demonstration microcatheter without difficulty.There was a slight kink to the distal end which likely occurred during advancing the guidewire into the microcatheter.An assignable cause of not conformed will be assigned to the reported 'guidewire difficult to advance' and 'hydrophilic coating peeling', as the issue was not confirmed during analysis.It is probable that the guidewire distal tip was kinked during use, therefore an assignable cause of procedural factors will be assigned to the analyzed 'guidewire kinked/bent'.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 FLOPPY 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: 18267399
• Report Number: 3008853977-2023-00051
• Device Sequence Number: 7900190
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: 08714729326250
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944677
• 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): 02/14/2024

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: 11/21/2024
• Device Catalogue Number: M001468070
• Device Lot Number: 30583514
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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: XT27 MICROCATHETER (STRYKER).
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Race: Asian