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 Consequences Or Impact To Patient (2199)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during procedure, when inserting the coil into microcatheter and pushed it out several times with the guidewire (subject device), the resistance was encountered; therefore, the guidewire (subject device) was withdrawn and found that the guidewire's tip (subject device) was disconnected.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added h4 manufacturing date ¿ added the device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 continuous flush was not maintained as instructed in the dfu to prime the catheter for smooth movement of the guidewire.This likely resulted in the reported resistance and caused the guidewire tip to fracture.Since there was a deviation from the supplied dfu that resulted in a different medical product response than intended by the manufacturer or expected by the user, an assignable cause of use error will be assigned to this complaint.
Event or Problem Description
It was reported that during procedure, when inserting the coil into microcatheter and pushed it out several times with the guidewire (subject device), the resistance was encountered; therefore, the guidewire (subject device) was withdrawn and found that the guidewire's tip (subject device) was disconnected.There were no reported clinical consequences to the patient.

• 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 ; CR 20101
• MDR Report Key: 10103196
• Report Number: 3008853977-2020-00017
• Device Sequence Number: 2654128
• Product Code: DQX
• UDI-Device Identifier: 08714729201212
• UDI-Public: 08714729201212
• Combination Product (Y/N): N
• 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): 08/19/2020

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: 10/17/2021
• Device Model Number: M001468060
• Device Catalogue Number: M001468060
• Device Lot Number: 24622551
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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: COIL (UNKNOWN MANUFACTURER); MICROCATHETER (UNKNOWN MANUFACTURER)