MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPLUSH - PLATINUM MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number DPL10020320

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2017

Event Type  malfunction  

Manufacturer Narrative

Product code: krd/hcg.The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.

Event Description

It was reported that during a coil embolization procedure, when the coil was pulled out of the package by the fellow, the surgeon thought the deltaplush coil (dpl10020320/ p11228) was longer than the size identified on the box.The procedure was delayed 10 minutes do to the event, but there were no patient adverse events.The procedure was completed with a same/like product.The device had been stored according to the labeling instructions.It was reported that the device would be returned for analysis.

Manufacturer Narrative

Conclusion: it was reported that during a coil embolization procedure, before the coil was used in the patient, when the coil was pulled out of the package by the fellow, the surgeon thought the deltaplush coil (dpl10020320/ p11228) was longer than the size identified on the box.The procedure was delayed 10 minutes do to the event, but there were no patient adverse events.The procedure was completed with a same/like product.The device had been stored per the labeling instructions.It was reported that the device would be returned for analysis.The device was returned for analysis.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned by the end user/hospital before being returned which may have produced further damage.As viewed through the returned packaging, the coil distal tip was found partially advanced outside the distal tip of the green introducer.The unit was returned entangled.Located at the distal tip of the skive adjacent to the clear/green junction, unreported damage of the device positioning unit (dpu) protruding through the sheath was found.Only the pouch was returned with a label removed as the outside box was not returned.There is no sheath damage at the protrusion site.The embolic coil was returned undamaged and is 4 mm x 10 cm.Four 4 mm x 10 cm and one 2 mm x 3 cm coil were used during the procedure.It is unlikely that the 4 mm x 10 cm coil was integrated into lot p11228 as the lot passed inspection and different lot numbers of the same catalog dpl100203-20 were assembled on the same tables and passed inspection for coil length per pic-cspec55665.The v notch of the resheathing tool was damaged.The locking mechanism has compression and stretching damage.No manufacturing defects were found.There are no more devices with lot # p11228 in the field.The manufacturing and inspection documentation for the following three lots from the same catalog were reviewed.The returned coil was a different size than expected based on the lot reported in this complaint.However, it is very unlikely that the coil was manufactured with an incorrect size.The same microcoil system catalog dpl100203-20 was manufactured in different lots (p11147 and p11257) prior to and after the complaint lot p11228 and the coil¿s length passed inspection on each lot.Additionally, a consignment and inventory search found no more devices of lot p11228 in the field and there have been no other complaints on this lot related to the coil¿s length.Review of complaint history also revealed no confirmed complaints in the past two years related to the coil¿s length.The document from the hospital providing barcodes of devices used in the procedure reveals that the size of the returned coil was the same size as four other coils used in the procedure.Therefore, it is possible that the user mistakenly used the 4 mm x 10 cm coil expecting it to match with the size of the deltaplush coil (dpl100203-20/p11228) based on the device label.Additionally, the label on the pouch and the outer box carton were not returned.Therefore, it is unknown whether the user had the labels on hand when using the device.Regarding the unreported damage evidence highly suggests that the damage occurred when the coil never advanced outside of the introducer sheath during the unsheathing process.Since the coil could no longer be advanced in this condition it is possible that this unusable system was put aside and given to the physician instead of the 2 mm x 3 cm coil needed to complete the procedure.Since there was no evidence that the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: DELTAPLUSH - PLATINUM MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6490961
• MDR Text Key: 72949368
• Report Number: 2954740-2017-00078
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528008057
• UDI-Public: (01)00878528008057(17)201031(10)P11228
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

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: 10/31/2020
• Device Catalogue Number: DPL10020320
• Device Lot Number: P11228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1