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

Model Number 2213-01

Device Problems Break (1069); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: no date provided, used the first date in the month of the aware date.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 300471279
• Report Number: 2124215-2022-36606
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729976622
• UDI-Public: 08714729976622
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K201792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1