MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ANGIOJET® SOLENT¿ OMNI; CATHETER, EMBOLECTOMY

Model Number 109681-001

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during unpacking the catheter was cracked.This angiojet solent catheter was selected; however, during unpacking it was noticed that the catheter was cracked midway on the catheter.It was noted that the crack was at a portion that would enter the patient.The device never entered the patient.The procedure was completed with another of the same device.

Manufacturer Narrative

Device evaluated by manufacturer: a visual and tactile examination of the returned complaint device revealed that the outer shaft had a kink in the tubing approximately 37cm from the tip of the catheter.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that during unpacking the catheter was cracked.This angiojet solent catheter was selected; however, during unpacking it was noticed that the catheter was cracked midway on the catheter.It was noted that the crack was at a portion that would enter the patient.The device never entered the patient.The procedure was completed with another of the same device.

• Brand Name: ANGIOJET® SOLENT¿ OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5046647
• MDR Text Key: 24771422
• Report Number: 2134265-2015-06180
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/05/2015

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: 02/28/2017
• Device Model Number: 109681-001
• Device Lot Number: 0000187830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1