MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC PRESIDIO 18 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number PC418205030J

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2011

Event Type  malfunction  

Event Description

The complaint received states that three cerecyte microcoils (pc4182050-30 / j10244) had resistance/friction in the microcoil, resulting in coil unravel/stretch and loss of target site.All three coils had very strong resistance at the tip of the mc.The coils could not be pushed out from the tip of the mc.First coil got unraveled during removal from the mc.Other two coils could not be removed from the mc due to the strong desistance; so they were removed together with mc.Using the same mc; presidio18 (other lot; 20mm 18mm 16mm) were deployed with no problem.The sales rep.Attended the procedure and there was no problem with the doctor's handling of the devices.Only one catheter will be returned to micrus; others were discarded at the hospital.

Manufacturer Narrative

This mdr is being submitted as part of retrospective review as a result of a recent fda audit and with accordance to the requirements of code of federal regulations ¿ 21 cfr part 803, medical device reporting.This is report 3 of 3 for (b)(6).Cc: the complaint received states that three cerecyte microcoils (pc4182050-30 / j10244) had resistance/friction in the microcoil, resulting in coil unravel/stretch and loss of target site.All three coils had very strong resistance at the tip of the mc.The coils could not be pushed out from the tip of the mc.First coil got unraveled during removal from the mc.Other two coils could not be removed from the mc due to the strong desistance; so they were removed together with mc.Using the same mc; presidio18 (other lot; 20mm 18mm 16mm) were deployed with no problem.The sales rep.Attended the procedure and there was no problem with the doctor's handling of the devices.Only one catheter will be returned to micrus; others were discarded at the hospital.(b)(6).The coil was returned undamaged.Multiple contributing factors were found that may have contributed to the resistance encountered by this coil.The evidence suggests that the first factor may have been due to distal interference inside the microcatheter caused by detached debris or by the microcatheter itself.A total of three coils found significant resistance at the distal tip of the microcatheter.The source of this interference cannot be determined.The second factor is the debris found adhering to the proximal end of the coil and inside the distal tip of the device positioning unit (dpu).Significant resistance was encountered during coil advancement outside the introducer sheath.Part of this debris field may have been from the separation of the outer sheath at the proximal end.However; no dark threads are used in the manufacture of this device which was also found in the same debris field.Therefore; the exact origin of the complete debris field cannot be determined.The third factor may have been the severe mechanical damage found to the sheath resulting in an opened skive.This was distal; but adjacent to where the tip coil was found protruding outside the sheath.In this condition; significant resistance will occur during coil advancement.The circumstances of how and where this damage occurred cannot be determined.The fourth factor as suggested by the evidence could have been due to where the resheathing tool was found.It was located past the soft braid.If the soft braid was used to advance the coil inside the microcatheter; significant resistance will occur.The fifth factor may have been due to the coil¿s socket ring being located down inside the pet angle ring.This would cause the articulating junction to be immobile and produce the loss of concentricity between the distal end of the dpu and the proximal end of the coil.This would also produce force against the side wall.However; it cannot be determined if this location of the coil¿s socket ring was the cause or the result of resistance encountered at the distal tip of the microcatheter.In addition; without the return of the transit 2 microcatheter and the two other microcoil systems involved in this procedure; it cannot be determined if these components contributed to the complaint event.Only one complaint device was returned; however, the complaint was confirmed on analysis.100% inspections are in place to prevent damaged products from leaving the facility and the dhr review confirmed that the product met specifications.No corrective action is required at this time.Review of the information suggests that procedural issues may have contributed to the reported and confirmed events.

• Brand Name: PRESIDIO 18 - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer (Section G): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4065997
• MDR Text Key: 17276376
• Report Number: 1226348-2014-00391
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2015
• Device Catalogue Number: PC418205030J
• Device Lot Number: J10244
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK PRESIDIO 18 MICROCATHETER