MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE SPIROFLEX® ANGIOJET® THROMBECTOMY SET; CATHETER, EMBOLECTOMY

Model Number 106553-001

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was not returned for analysis.Lot number was not provided therefore a ship history of previous lots sent to the customer was reviewed.Dhr found no issues.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).

Event Description

It was reported that the shaft was cracked.A spiroflex® angiojet® thrombectomy set was selected for use.During preparation outside of the patient, it was observed that the shaft was cracked.The device was then not used for the procedure.

• Brand Name: SPIROFLEX® ANGIOJET® THROMBECTOMY SET
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7754415
• MDR Text Key: 116156032
• Report Number: 2134265-2018-06977
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 106553-001
• Device Catalogue Number: 106553
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1