MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUSELECT; CATHETER, CONTINUOUS FLUSH

Model Number	2213-01
Medical Device Problem Codes	Break (1069); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: no date provided, used the first date in the month of the aware date.
Event or Problem Description
It was reported that the catheter broke.A 155cm truselect was selected for use.During preparation, the catheter was unable to be pulled out from the plastic shell and the catheter broke.There were no patient complications.
Additional Manufacturer Narrative
B3: date of event: no date provided, used the first date in the month of the aware date.Device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of a trueselect 155cm microcatheter.The device was returned partially in the shipping hoop.The hub was detached 5.4cm from the hub when received from the customer site.The shipping hoop was hydrated, and the device was removed with no issues.There is evidence the device was used contrary to product labeling per the instructions for use (ifu).The ifu states: before removing the microcatheter from the carrier hoop, flush the carrier hoop with heparinized saline or regular saline to activate the hydrophilic coating and aid in removal.The y-connector fitting attached to the carrier hoop may be used to facilitate flushing.Once the product is hydrated, do not allow it to dry.Detach the microcatheter hub from the angled clip, and gently withdraw the microcatheter, looping if necessary.Do not force the microcatheter from the carrier hoop.If resistance is felt during removal, re-flush the carrier hoop with heparinized saline or regular saline.Do not reinsert the product into the carrier hoop.
Event or Problem Description
It was reported that the catheter broke.A 155cm truselect was selected for use.During preparation, the catheter was unable to be pulled out from the plastic shell and the catheter broke.There were no patient complications.

• Brand Name: TRUSELECT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15469389
• Report Number: 2124215-2022-36606
• Device Sequence Number: 2832515
• Product Code: KRA
• UDI-Device Identifier: 08714729976622
• UDI-Public: 08714729976622
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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: 05/16/2024
• Device Model Number: 2213-01
• Device Catalogue Number: 2213-01
• Device Lot Number: 0029413520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown