MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PRESIDIO 18 - CERECYTE MICROCOIL; CNV DCS COILS

Model Number PC418155030

Device Problems Failure to Advance (2524); Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2014

Event Type  malfunction  

Event Description

During a coil embolization of the patient¿s iia, it was reported that the presidio18 (pc4181550-30/c25650) coil had resistance at 30cm from the middle section of prowler select plus (606-s255fx/16114392) microcatheter (mc).The coil was attempted to be recover, but the coil was stuck.The complaint coil was withdrawn together with the complaint mc, and another mc and a coil were used to continue the procedure, which was successfully completed without further issues.There was no patient injury/complications reported.The complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends, etc.) was noted on the products by visual inspection.Also no damages were reported on the concomitant devices after the event.There was no stretching or unintended detachment of the coil observed in the vessel or in the microcatheter.It was reported that a radifocus gt gw (terumo, type unknown), a sion blue (asahi intecc, type unknown), a shuttle sheath (cook inc., type unknown), a prowler select plus 45°(lot unknown ¿ different from the complaint product), an unplast (terumo, type unknown), and enpower detachment control box (lot unknown) were also used for the above procedure.No further details of the concomitant devices are available.The vessel was not tortuous and not calcified, and approached was obtained from the right femoral artery.The complaint products will be returned for evaluation.No further information is available.

Manufacturer Narrative

(b)(4).The product was received for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.This is one of two products used and being reported under complaint (b)(4).

Manufacturer Narrative

Product was received for analysis.Additional information will be submitted within 30 days of receipt.This is one of two products associated with (b)(4).

Manufacturer Narrative

Limited information was received.The prowler select plus microcatheter was returned.As viewed through the returned packaging, it was observed that the complete length of the core wire and proximal section of the coil were outside the sheath and the entire microcoil system (minus coil) was returned severely damaged.Due to the damage to the microcoil system no advancement testing could be performed.The coil was returned undamaged.Socket ring junction.A copious amount of blood was found adhering to the coil and inside the introducer sheath.Ball tip.Located on the top proximal end of the resheathing tool in the open cutout section, the v notch has been fractured with the extended v notch edge raised above the surface plane.The locking mechanism has compression and stretching damage.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.As viewed through the returned packaging, it was observed that the complete length of the core wire and proximal section of the coil were outside the sheath and the entire microcoil system (minus coil) was returned severely damaged.Due to post-procedural handling and packaging, the circumstances of how and when this damage occurred cannot be determined.The coil was returned undamaged.Located on the top proximal end of the resheathing tool in the open cutout section, the v notch has been fractured with the extended v notch edge raised above the surface plane.The locking mechanism has compression and stretching damage.Based on this information and review of the lot that indicated that this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint, no corrective actions will be taken at this time.Additional information will be submitted within 30 days of receipt.This is one of two product reported under (b)(4).

Manufacturer Narrative

During a coil embolization of the patient¿s iia, it was reported that the presidio18 (pc4181550-30/c25650) coil had resistance at 30cm from the middle section of prowler select plus (606-s255fx/16114392) microcatheter (mc).The coil was attempted to be recover, but the coil was stuck.The complaint coil was withdrawn together with the complaint mc, and another mc and a coil were used to continue the procedure, which was successfully completed without further issues.There was no patient injury/complications reported.The complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends, etc.) was noted on the products by visual inspection.Also no damages were reported on the concomitant devices after the event.There was no stretching or unintended detachment of the coil observed in the vessel or in the microcatheter.It was reported that a radifocus gt gw (terumo, type unknown), a sion blue (asahi intecc, type unknown), a shuttle sheath (cook inc., type unknown), a prowler select plus 45°(lot unknown ¿ different from the complaint product), an unplast (terumo, type unknown), and enpower detachment control box (lot unknown) were also used for the above procedure.No further details of the concomitant devices are available.The vessel was not tortuous and not calcified, and approached was obtained from the right femoral artery.The complaint products will be returned for evaluation.No further information is available.As viewed through the returned packaging, it was observed that the complete length of the core wire and proximal section of the coil were outside the sheath and the entire microcoil system (minus coil) was returned severely damaged.Due to post-procedural handling and packaging, the circumstances of how and when this damage occurred cannot be determined.The coil was returned undamaged.Located on the top proximal end of the resheathing tool in the open cutout section, the v notch has been fractured with the extended v notch edge raised above the surface plane.The locking mechanism has compression and stretching damage.Based on this information and review of the lot that indicated that this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint, no corrective actions will be taken at this time.The reported event could not be confirmed, since the unit was returned severely damage.Additionally, a lab coil passed though the returned microcatheter.Based on the information procedural factors including handling may have contributed to the event.This lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint, no corrective actions will be taken at this time.Therefore, no corrective actions will be taken at this time.(b)(4).

• Brand Name: PRESIDIO 18 - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; 821 fox lane; san jose, CA 95131 ; 5088288310
• MDR Report Key: 4205071
• MDR Text Key: 4981151
• Report Number: 2954740-2014-50021
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2019
• Device Model Number: PC418155030
• Device Catalogue Number: PC418155030
• Device Lot Number: C25650
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2014
• Date Device Manufactured: 04/17/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR