MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number M001314661

Device Problems Entrapment of Device (1212); Occlusion Within Device (1423); Unintended Movement (3026)

Patient Problems Thrombosis (2100); No Consequences Or Impact To Patient (2199)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-09036.It was reported that coil migration occurred.The target aneurysm was located in the moderately tortuous and moderately calcified right internal iliac artery(iia).An imager 2 diagnostic catheter was advanced to the target region and the iia was cannulated.Embolization was performed in the superior gluteal artery, bifurcation of inferior gluteal artery, aneurysm and iia main.Several coils were deployed successfully.A 6mm x 20cm interlock¿-35 coil was then selected for use.The coil was delivered through the catheter without resistance.The physician was under the impression that the coil deployed successfully; however, angiography confirmed that the coil had unraveled and remained inside the catheter.The physician attempted to push the coil out from the catheter by flushing the catheter as well as using a.035 guidewire.These attempts were not successful.The imager 2 catheter then "bounced" and the interlock¿-35 coil jumped into the common iliac artery (cia).The physician inserted a microcatheter and was able to separate the coil from the imager 2 catheter.It was not possible to remove the coil from the cia, therefore it was left in this position.The procedure was completed with another interlock¿-35 coil.There were no further patient complications and the patient is in good condition.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual examination showed that the device had a kink approximately 35cm from the tip.The inner lumen was checked with an interlock 35 occlusion system wire and there was found to be a blockage inside of the lumen.The wire would not fully transcend through the entire length of the device.The lumen showed a blocked area from a clot formation which affected patency of the lumen.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 further reported that "catheter bounced" meant that the catheter got disengaged from the blood vessel.Resistance was encountered when removing the coil and the physician used force to pull the coil.The coil unraveling was due to possible thrombosis in the imager catheter.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer (Section G): TFX ENGINEERING LIMITED T/A; estate; limerick
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6012376
• MDR Text Key: 56909479
• Report Number: 2134265-2016-09518
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K120893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001314661
• Device Catalogue Number: 31-466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2016
• 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
• Patient Outcome(s): Required Intervention