MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 014; WIRE, GUIDE, CATHETER

Catalog Number	M001468050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during the procedure, while inserting the subject guidewire into the non-stryker microcatheter the proximal section of the guidewire broke.No clinical consequences were reported to the patient.
Additional Manufacturer Narrative
Expiration date: added.Product available to stryker and returned date: updated.Device evaluated by mfg :update.Summary attached: updated.Manufacturing date: added.A dhr (device history record) review indicated that the device met all required specifications when released.The transend guidewire was examined under magnification.During the investigation it was discovered that the guidewire was received in two fragments.Magnified examination of the fracture site showed the core wire was fractured.The guidewire was slightly bent at the fracture site.From the condition of the guidewire at the fracture site, it appears that the guidewire separated due to excessive bending and excessive torque.The bending and fracture on the guidewire appeared to be due to excessive manipulation.Functional analysis was not able to be performed due to the anomalies found on the product.Additional information provided by the customer indicated that the device was confirmed to be in good condition after unpacking and preparation, no resistance was observed while inserting the guidewire into the non-stryker microcatheter (tangent, unknown id), and the proximal section of the guidewire broke during insertion into the microcatheter.The guidewire appeared to have been separated due to excessive bending and torqueing.Based on the device analysis, a probable cause of handling damage has been assigned to the reported event and analyzed anomalies as these issues appear to be due to handling of the product during the clinical procedure.
Event or Problem Description
It was reported that during the procedure, while inserting the subject guidewire into the non-stryker microcatheter the proximal section of the guidewire broke.No clinical consequences were reported to the patient.

• Brand Name: TRANSEND EX 014
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101
• MDR Report Key: 8093063
• Report Number: 3008853977-2018-00066
• Device Sequence Number: 16463529
• Product Code: DQX
• UDI-Device Identifier: 08714729187332
• UDI-Public: 08714729187332
• Combination Product (Y/N): N
• 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): 01/08/2019

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: 11/17/2019
• Device Catalogue Number: M001468050
• Device Lot Number: 21402242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 01/08/2019
• 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 (TANGENT)