MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND 14 FLOPPY 300CM; WIRE, GUIDE, CATHETER

Model Number	M003468150
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2021
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 operator found tip of guidewire (subject device) damaged without hydrophilic coating.The problem was noticed outside patient's body and no patient was impacted.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, an attempt appeared to have been made to shape the distal tip of the guide wire, the guidewire was noted to be kinked/bent, the distal tip was noted to be within specification, the proximal tip was noted to be within specification.A functional test was not required.The device failed to meet specifications when received for complaint investigation based on the analyzed anomaly 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.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging, the device was reported as an out of box failure.The returned guidewire was inspected, and the guidewire tip appeared to have been shaped and a kink/bent was also noted at the distal end.The proximal end was within specification.There is no requirement for hydrophilic coating to be present on the very proximal end of the guidewire.The hydrophilic coating only goes over the poly sleeve which is the distal section of the wire.It is possible the user mistook the proximal end section to be the reported issue however the device was confirmed to be manufactured to specification.Since the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event, an assignable cause of not confirmed will be assigned to the as reported ¿hydrophilic coating peeling¿.The as analyzed ¿guidewire distal end kinked/bent¿ will be assigned handling damage as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that the operator found tip of guidewire (subject device) damaged without hydrophilic coating.The problem was noticed outside patient's body and no patient was impacted.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TRANSEND 14 FLOPPY 300CM
• 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: 12340312
• Report Number: 3008853977-2021-00030
• Device Sequence Number: 3737054
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: 08714729441748
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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: 08/04/2022
• Device Model Number: M003468150
• Device Catalogue Number: M003468150
• Device Lot Number: 25812224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/08/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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
• Patient Sex: Unknown
• Patient Race: Asian