MAUDE Adverse Event Report: DEPUY SYNTHES (CODMAN) HELIPAQ CERECYTE COIL; COIL, NEUROVASCULAR EMBOLIZATION

Model Number CHE180620-30

Device Problems Retraction Problem (1536); Patient-Device Incompatibility (2682)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/08/2018

Event Type  malfunction  

Event Description

A detachable coil was being used to embolize an endovascular leak in a patient status post endovascular repair of aortic aneurysm.The coil was advanced via the accessed l1 artery to the site where deployment was desired within the aortic aneurysm sac; the coil proved to be too long and decision was made to retract the coil rather than deploy it.Resistance was encountered when trying to pull the coil back out through the deployment microcatheter.It became apparent that the coil was not retracting despite pulling on the deployment wire.Instead, it appeared that the coil was unraveling.Decision was made to pull the microcatheter with the coil in it back out through the 5f catheter.The microcatheter came out; however, the coil remained in the patient, partially deployed in the aortic sac and extending back through the l1 artery into the aortic lumen.The bulk of the unraveled coil within the aortic lumen was removed using various techniques including a snare device.A tiny fragment remains protruding 10-20 mm into the aortic lumen.This is a very fine wire fragment and its protrusion into the aorta is of no clinical significance (opinion).

• Brand Name: HELIPAQ CERECYTE COIL
• Type of Device: COIL, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): DEPUY SYNTHES (CODMAN); 325 paramount drive; raynham MA 02767
• MDR Report Key: 7600522
• MDR Text Key: 111043713
• Report Number: 7600522
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2020
• Device Model Number: CHE180620-30
• Device Catalogue Number: CHE18062030
• Device Lot Number: C39043
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/11/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR