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 Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported the catheter cracked.Attempting to advance a spiroflex (tm) angiojet (tm) thrombectomy catheter into the thrombus site, the catheter cracked and bleeding came out from the catheter.The catheter was exchanged to another of the same device and the procedure was completed.No patient complications were reported and the patient's status is fine.

Manufacturer Narrative

Returned product consisted of a angiojet spiroflex thrombectomy system.Device analysis determined that the condition of the device was consistent with the complaint incident.Visual and tactile inspection of the outer shaft noted that there was a kink and a hole approximately 9 ½ centimeters from the manifold 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 operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported the catheter cracked.Attempting to advance a spiroflex angiojet thrombectomy catheter into the thrombus site, the catheter cracked and bleeding came out from the catheter.The catheter was exchanged to another of the same device and the procedure was completed.No patient complications were reported and the patient's status is fine.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5213607
• MDR Text Key: 31099495
• Report Number: 2134265-2015-07651
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

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 Model Number: 106553-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2015
• Initial Date FDA Received: 11/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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