MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND .014 FLOPPY 300 CM ( IC 300 ); WIRE, GUIDE, CATHETER

Model Number	M003468150
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that the extremity of the guidewire had peeled off.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The cause of the reported issue could not be definitively determined.
Event or Problem Description
It was reported that the extremity of the guidewire had peeled off.There were no reported clinical consequences to the patient.
Event or Problem Description
It was reported that the extremity of the guidewire had peeled off.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.During visual inspection, the subject guidewire distal section and hydrophilic coating was examined.The distal core wire and hydrophilic coating was found to be intact.The guidewire ptfe(polytetrafluoroethylene) coating was examined under magnification had peeled off at the proximal end but was present along the rest of the ptfe length.A functional test was performed with a demonstration sl-10 microcatheter and it was advanced through the distal tip without issue.The reported complaint was confirmed based on analysis.The subject 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.Analysis of the returned device found the hydrophilic coating had peeled off the proximal end which most likely occurred during manipulation of the device.An assignable cause of handling damage will be assigned to the as reported subject guidewire delamination since this complaint appears to be associated with handling of the product during the clinical procedure.

• Brand Name: TRANSEND .014 FLOPPY 300 CM ( IC 300 )
• 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
• MDR Report Key: 8344638
• Report Number: 3008853977-2019-00018
• Device Sequence Number: 16549331
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: 08714729441748
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K022357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2021

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: 02/26/2020
• Device Model Number: M003468150
• Device Catalogue Number: M003468150
• Device Lot Number: 21792458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 03/19/2019; 01/13/2021
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/25/2019; 01/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1