MAUDE Adverse Event Report: COOK INC RETRACTA DETACHABLE EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Catalog Number	MWCER-35-14-10
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
A (b)(6) female patient with pseudoaneurysm on the anastomosis of a bypass, location side cia/eia was having a coiling of the hypogastric artery to prevent pseudoaneurysm to grow through retrograde flow ofter covered stent placement procedure.There was unstable positioning of the c2 catheter in the hypogastric artery; therefore, a decision was made to use cook retracta detachable embolization coil.The first 2 retracta placements ( 6 and 8mm ) was placed without difficulties.The 10mm retracta was advanced; but friction was felt by the doctor.When he tried to remove the retracta, the coil remained inside the catheter (approximately 2cm was outside the catheter ) while the delivery wire was out of the distal end of the catheter as they were separated.According to the initial reporter, the patient did require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation/evaluation: during the course of the investigation, a visual inspection, along with a review of the complaint history, quality control, device history record, instructions for use (ifu), manufacturing instructions, dimensional verification, and a drawing of the returned used and damaged product was conducted.The returned delivery wire system was examined.As received, the delivery wire was lodged in the needle assembly.An attempt was made to remove the delivery wire from the needle assembly, but were not able to do so with minimal force.When the delivery wire was pulled with minimal force, the wire recoiled back into the cannula, indicating presence of at least the proximal coil.It was pulled with more than minimal force and was able to stretch the proximal coil and break it loose.A 0.018" cook wire guide was inserted into the needle assembly and dislodged the proximal coil.There was significant blood and biomaterial on the proximal coil.The proximal coil measured 8.0 mm which confirms the dimension.The device is packaged with an ifu; which includes device description, intended use, warnings, precautions, product recommendations and instructions for placement, delivery technique and recommendations for coil size selection.The ifu states in step 6, "under fluoroscopic visualization, slowly advance the delivery wire until the entire length of the coil exits the distal end of the catheter.Ensure that the junction remains positioned just inside the catheter tip.Note: advancing the delivery wire slowly allows the junction to be seen more easily and reduced the risk of damaging it.Note: if significant resistance is encountered during coil advancement, do not continue advancing.Retract the delivery wire slightly, then gently re-advance it.If there is still significant resistance, withdraw the deliver wire from the catheter and try using a new coil with a shorter length." the reason for the coil being caught at the distal end of the catheter and disconnecting from the delivery wire are not clear and could not be determined with certainty.We will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
A (b)(6) female patient with pseudoaneurysm on the anastomosis of a bypass, location side cia/eia was having a coiling of the hypogastric artery to prevent pseudoaneurysm to grow through retrograde flow of the covered stent placement procedure.There was unstable positioning of the c2 catheter in the hypogastric artery; therefore, a decision was made to use cook retracta detachable embolization coil.The first 2 retracta placements ( 6 and 8mm ) was placed without difficulties.The 10mm retracta was advanced; but friction was felt by the doctor.When he tried to remove the retracta, the coil remained inside the catheter (approximately 2cm was outside the catheter ) while the delivery wire was out of the distal end of the catheter as they were separated.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: RETRACTA DETACHABLE EMBOLIZATION COIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5498223
• Report Number: 1820334-2016-00173
• Device Sequence Number: 498448
• Product Code: KRD
• UDI-Device Identifier: 10827002341996
• UDI-Public: (01)10827002341996(17)190301(10)4831356
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K123712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: MWCER-35-14-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/26/2016
• Device Age: 23 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2016
• Supplement Report FDA Received Date: 06/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 50