MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC XTRASOFT ORBIT GALAXY DETACHABLE COIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640HX0206
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial/final mdr report being submitted for this complaint with associated manufacturing mfr# 3008264254-2016-00057.Additional procode: krd.(b)(4).Four galaxy coils, prowler lpes 45 deg.A non-sterile og helical xtrsoft coil 2x6 was received coiled inside a plastic bag in a pouch of original packaging.The hypotube was inspected and was found to be kinked at 76, 94.8 and 144.8cm from the proximal end of the hub.The introducer was received un-zipped, without damage and with residues of dry blood on the inside.The support coil and gripper were received outside of the introducer; no damages were noted on the support coil.Rest of the embolic coil was found inside the catheter body.The gripper was inspected under the vision system and was found to be damaged.The soldered section between headpiece and the coil loops was not fractured which means that the solder had a good adhesion to the headpiece.Catheter body was inspected under the vision system; scrunch was noted on the catheter which may be caused by application of excessive force on it.Rest of the embolic coil was found in the distal part of the catheter.The coil was found to be stretched and busted and the suture of the embolic coil was broken.Part of the alligator snare (unknown) device was found in the other section of the catheter and was noted to be cut.Residues of dry blood were noted on the body.The surface of catheter body presented evidence of elongation at the surroundings areas of the separation and cut condition.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The reported failure of the og xtrsoft coil being unraveled and stretched was confirmed.The condition found on the embolic coil was apparently caused due to application of excessive force on the device but it could not be conclusively determined.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process and procedural factors appear to have contributed to this failure.Therefore no corrective action will be taken at this time.
Event or Problem Description
As reported by a healthcare professional, during elective coiling of a ruptured aneurysm in the anterior communicating artery, physician reported a stretched coil.Physician had previously placed 4 galaxy coils through a prowler lpes 45 degree microcatheter without incident when he attempted to place the final "finishing" coil, a galaxy xtrasoft 2x6 ((b)(4)).Physician reported that during the second attempt to reposition the coil, it appeared that the coil prematurely detached.It was then determined that the coil had stretched not detached, when a stretched segment was pushed into the left middle cerebral artery causing a temporary occlusion.Physician retrieved the coil with an alligator snare and removed the entire segment of coil.Physician did not report any abnormalities with the coil during prep or initial advancement.Continuous flush was maintained.There were no patient injuries due to the reported event.The patient is a (b)(6) year old female whose vessels were reported to be of low tortuosity.The patient was a hunt hess grade 5 at admission and remains hospitalized, recovering.The complaint product is available for analysis.
Additional Manufacturer Narrative
This is a follow up mdr report being submitted for this complaint with associated mfr # 3008264254-2016-00057 and 3008264254-2016-00058.This is a final mdr report.There were no damages reported on the microcatheter prior to use.Initially during the procedure a one to one relationship between the coil and delivery tube was verified with fluoro prior to repositioning.After repositioning the coil several times it was then determined that the coil had stretched not detached, when a stretched segment was pushed into the left middle cerebral artery causing a temporary occlusion.The coil was removed using a snare (type/lot unknown) and a competitor¿s stent-retriever.Upon removing the coil it was found that the coil had stretched and detached; the microcatheter was removed along with the coil.It was reported that patient deceased several days after the procedure; she had presented prior to the procedure with a poor grade and subarachnoid hemorrhage.Concomitant medical product: solitaire stent retriever.

• Brand Name: XTRASOFT ORBIT GALAXY DETACHABLE COIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 5949308
• Report Number: 3008264254-2016-00057
• Device Sequence Number: 13604413
• Product Code: HCG
• UDI-Device Identifier: 10886704030720
• UDI-Public: (01)10886704030720(17)161231(10)17164555
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 640HX0206
• Device Lot Number: 17164555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2016
• Supplement Report FDA Received Date: 09/23/2016
• Patient Sequence Number: 1
• Patient Age: 36 YR