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

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

The contact at the hospital reported that during the emergency coil embolization to stop gastrointestinal hemorrhage two deltamaxx coils (both cdx180312-30/c25979) did not loop in the target aneurysm and could not be rezipped.Apart from the fact that the diameter of the target vessel was 3mm, the patient¿s detail such as sex, dob, weight, and the level of tortuousness and calcification of the patient¿s vessel were not available.It was reported that an excelsior sl-10 (stryker) was used for this procedure.Although both complaint deltamaxx coils were inserted into the target lesion site, neither microcoil looped at the site because they did not conform to vessel walls.In both cases, the physician attempted to re-sheath the coils.However, the re-sheathing tool of the 1st deltamaxx got damaged while being zipped back only slightly.The 2nd deltamaxx was zipped back farther than the 1st, but its re-sheathing tool also got damaged while being zipped.The procedure was successfully completed with other coils without further issues.There were also no patient injury/complications.There was no report of if the procedure was delayed or not.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.No visible defect/damage was noted on the product prior to the events.There was no unintended detachment of the coil observed in the vessel or in the microcatheter.The complained products have already been disposed.No further information is available.

Manufacturer Narrative

Concomitant devices: another deltamaxx coil (cdx180312-30/c25979); excelsior sl-10 microcatheter.The deltamaxx (cdx180312-30, lot c25979) will not be returned, therefore the root cause of the coils looping not conforming to the vessels walls and the failure to be resheathed after removal cannot be determined.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 the root cause could not be confirmed and review of the manufacturing process did not present any issues related to the complaint, no corrective actions will be taken.This complaint is related to mfr report #2954740-2015-00005.

Manufacturer Narrative

The deltamaxx ((b)(4), lot c25979) will not be returned, therefore the root cause of the coils looping not conforming to the vessels walls and the failure to be resheathed after removal cannot be determined.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 the root cause could not be confirmed and review of the manufacturing process did not present any issues related to the complaint, no corrective actions will be taken.

• Brand Name: DELTAMAXX - 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: 4414834
• MDR Text Key: 16307192
• Report Number: 2954740-2015-00004
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Model Number: N/A
• Device Catalogue Number: CDX18031230
• Device Lot Number: C25979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2015
• Date Device Manufactured: 04/29/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1