MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRANSEND; WIRE, GUIDE, CATHETER

Model Number	81735
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a foreign object was present in the package.A model-transend 135cm long guide catheter will be used for treatment.When unpacking the device, an insect object was observed inside the box.This device was not used with the patient.The procedure was completed with another of same device.There were no patient complications.
Event or Problem Description
It was reported that a foreign object was present in the package.A model-transend 135cm long guide catheter will be used for treatment.When unpacking the device, an insect object was observed inside the box.This device was not used with the patient.The procedure was completed with another of same device.There were no patient complications.It was further reported that the foreign objects were plastic fragments and not the initially reported insects.
Event or Problem Description
It was reported that a foreign object was present in the package.A model-transend 135cm long guide catheter will be used for treatment.When unpacking the device, an insect object was observed inside the box.This device was not used with the patient.The procedure was completed with another of same device.There were no patient complications.It was further reported that the foreign objects were plastic fragments and not the initially reported insects.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device returned with its original pouch batch 23167942.There was a mosquito between the label and the original pouch.Also, there were some particles inside the pouch.It was noted that the pouch was returned already open.

• Brand Name: TRANSEND
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8453416
• Report Number: 2134265-2019-03029
• Device Sequence Number: 2989558
• Product Code: DQX
• UDI-Device Identifier: 08714729326274
• UDI-Public: 08714729326274
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K941710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2019

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: 01/09/2021
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0023167942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 03/26/2019; 04/30/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/11/2019; 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1