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

Model Number N/A

Device Problems Fracture (1260); Difficult To Position (1467); Unraveled Material (1664); Failure to Advance (2524); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

The contact from the facility reported that during basilar artery embolization, various introducer damages were experienced when using the deltapaq (cdf100210-30 / c14269) and deltamaxx (cdx180312-30 / c31669).The deltapaq also could not be properly positioned in the aneurysm initially.The complaint deltapaq was delivered to the target lesion site, but because the physician was unable to properly place the microcoil into the target site, the physician decided to recover the coil.However, when the re-sheathing tool was slid back, the introducer sheath was split open at about 10cm from the distal end.Although the physician managed to re-sheath deltapaq, the split was still slightly open.The physician pushed the dpu into the mc to re-deliver the coil, but the dpu got protruded from the split and could not be inserted into the mc.It was replaced with another coil of the same size, which was successfully implanted into the target site.The complaint deltamaxx was then used to embolise another vessel, but when it was un-sheathed, the re-sheathing tool became damaged.The microcoil was delivered to the target vessel, but the microcoil was wrong size.The physician tried to re-sheath the coil, yet it could not be properly sheathed back with the damaged re-sheath tool, and became unfit for re-use.The procedure was completed without further issues.There were no patient injury/complications.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 damage was noted on the products prior to the events.There was no unintended detachment of the coils observed in the mc or in the vessel.The complained products will be returned for analysis.No further information is available.Product analysis revealed that the returned coil lot c31669 was entangled and lot c14269 was unraveled and fractured.

Manufacturer Narrative

Concomitant devices: deltamaxx (cdx180312-30 / c31669), excelsior (stryker, type unknown), enpower dcb (lots unknown).Limited information was received.The unspecified excelsior microcatheter and rotating hemostatic valve (rhv) were not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned/rinsed before being returned which may have produced further damage.It is also unknown if the device was further manipulated and/or inspected post-procedurally.Any trace evidence that may have been complaint related may have been altered or removed prior to being returned.Located proximal, but adjacent to the clear/green junction the coil protrudes outside the sheath.Located at the protrusion site the following damage was found: the coil unraveled out of the soldered section and fractured.The coil was severely compressed and buckled in multiple sections leading up to the protrusion site.The skive was found to have been opened up.Past the protrusion site the coil is undamaged.No manufacturing or material defects were found.Due to limited information and the lack of photographic evidence it cannot be determined why the coil could not be originally deployed into the aneurysm.The most likely contributing factor to the resheathing difficulty may have occurred when the resheathing tool was advanced onto the proximal end of the green introducer.When the resheathing tool was retracted for resheathing the coil, it may have opened up the skive producing the damage that may have allowed the coil to protrude outside the sheath.In this condition resheathing the coil cannot be performed.The complaint event narrative confirms that the sliding of the resheathing tool in the proximal direction most likely caused the sheath to split open.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿¿continue sliding the introducer tip until just before the tip reaches the distal end of the re sheathing tool, leaving approximately 1 inch of the unsheathed introducer sheath still visible.¿ in addition, without the complete identification as to the product catalog number or the return of the microcatheter and the rhv used in the procedure it cannot be determined if this component had any additional contributions to the complaint event.Concerning the coils reinsertion difficulty into the microcatheter, this was due to the coil already protruding outside the sheath.When attempting to advance the coil into the microcatheter, the anchored coil caused further compression, buckling, and fracturing of the coil at the soldered section.In this condition, the coil cannot be advanced into the microcatheter.Dhr: 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.Based on the information and the analysis, the event was confirmed, however procedural factors outlined in the ifu likely contributed to the event.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Additional damage was discovered on the device upon product return.It cannot be determined when these failures occurred, whether during the procedure or post-procedurally.Additionally, review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.This report is related to mfr report #2954740-2015-00126.

• Brand Name: DELTAPAQ - 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: 4827655
• MDR Text Key: 18385899
• Report Number: 2954740-2015-00127
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K080437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2017
• Device Model Number: N/A
• Device Catalogue Number: CDF10021030
• Device Lot Number: C14269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2015
• Initial Date Manufacturer Received: 06/04/2015
• Initial Date FDA Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1