MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT MICROCATHETERS; CES MICROCATHETERS (KRA)

Catalog Number 606S155X

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2015

Event Type  malfunction  

Manufacturer Narrative

It was reported by the hospital contact that the specialist used a prowler select (606s155fx/15946439) to pass the stent (details unknown) and a prowler select (606s155x/16038288) to pass the coils (details unknown).He begins to deploy coils without any problem.The surgeon decides to place stent and more coils.The surgeon deploys the stent and when finished the aneurysm embolization, the coils: deltapaq (dfs10030620/c26953), deltapaq (dfs10025620/c27843), and the last coil deltapaq (dfs10025420/g15847) do not pass.The surgeon decides to spend the micro-guide to verify what happens and micro-guide does not go into the micro-catheter.The surgeon decides to change the micro-catheter and put another (details unknown).The last coil was removed first followed by the microcatheter.The other micro-catheter is not working.The products were discarded.An adequate continuous flush was maintained through the microcatheter.The surgery was delayed about 25 minutes.The patient had a large aneurysm neck which was neither calcified nor tortuous.Based on the information, the event was not confirmed.The product was not returned for analysis; however procedural factors may have contributed to the event.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.Therefore, no corrective actions will be taken at this time.This is an initial/final report.Concomitant medical products and therapy dates: two micro guides (details unknown).Stent (details unknown).Another microcatheter (details unknown).Deltapaq (dfs10025420/g15847).Deltapaq (dfs10025620/c27843).Deltapaq (dfs10030620/c26953).Prowler select (606s155fx/15946439).Coils (details unknown).

Event Description

It was reported by the hospital contact that the specialist uses two micro guides (details unknown), by a micro-guide passes stent (details unknown) and other micro-guide passes the coils.He begins to deploy coils without any problem.The surgeon deploys the stent and when finished the aneurysm embolization, the coils do not pass.The surgeon decides to spend the micro-guide to verify what happens and micro-guide does not go into the micro-catheter.The surgeon decides to change the micro-catheter and put another (details unknown).The other micro-catheter is not working.The products were discarded.

Manufacturer Narrative

Please note that the dob and demographics were updated, and the date of the initial event.It was reported that this truline study for patient with (b)(6) had subarachnoid hemorrhage during the index procedure when the third orbit galaxy 5 mm x 15 cm (15763742) was implanted, and at the one year follow-up, angiography was performed that revealed realization.During the index procedure, while positioning the 3rd coil, a slight pressure was applied and the hemorrhage occurred.Additionally, it was noted that maybe the presence of the balloon contributed somewhat as it may have limited the movement of the microcatheter into the sac.No other devices contribute to the event.Also, minor recanalization was reported post index procedure.The physician indicated only the third coil caused the subarachnoid hemorrhage.During the index procedure, a single aneurysm was treated with ten codman coils (640cf0515/15763742 - galaxy complex fill 5mmx15cm 41; 640cx3509 /15763742; 640cx3505 / 15571266; 640cx2505/15761907; 640cx2535/15710778; 640cx02525/15761909; 640cx0202/15710778, 640cx02525/15757695, 640cf0620/15761620, & pc410073030/c1260) were implanted using an occlusion balloon assisted technique.Non-codman guide, microcatheter, wire and balloon were used.Satisfactory results were obtained, there was residual neck; however, the sac occlusion was 90-99%.During the index procedure, the order of coil implantation consisted of first presidio 10 cerecyte coil 7mm x 30 cm, second orbit galaxy 6 mm x 20 cm, and third orbit galaxy 5 mm x 15 cm, and the reason why the aneurysm was left with 90-99% instead of 100% that there was a residual filling at the neck, whereas the sac was completely excluded, and the physician was afraid of a possible clot formation after the hemorrhage.Clinical evolution was favorable, and the patient quit the hospital on day 5 without any deficit or headaches.At the 30 day follow up visit, the patient had no symptoms and no report of adverse event.At the one year follow up, the patient remained symptom free.Angiography was performed that revealed there was residual neck filling and occlusion was 90-99%; however, comparison to the index procedure films showed the aneurysm to be worse with recanalization, classified as minor.There is no report of treatment of recanalization.Further follow-up showed a recanalization, for which a second embolization was successfully performed on nineteen months after the index procedure.The target aneurysm was located at aca (anterior communicating artery), was non-ruptured, sac size of 7.8mm with a neck of 4.7mm.This patient presented with no symptoms.Past medical history includes current smoker, hypertension and a negative family history for aneurysm.The patient has a history of diabetes, smoker, hypertension treated with coversyl 2mg, and hyperlipidemia.The patient has a family history of aneurysm.Aneurysm height was 7.80mm, neck was 4.70mm, non-ruptured, and the patient had not symptoms.Other devices used consisted of 2 introducer, microcatheter echelon 14, guidewires transend 14, balloon 5 hyperform 4x7mm and balloon eclipse 7mm.

Manufacturer Narrative

(b)(4).

• Brand Name: PROWLER SELECT MICROCATHETERS
• Type of Device: CES MICROCATHETERS (KRA)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: kimberly soter ; 325 paramount dr; raynham, MA 02767 ; 5089777396
• MDR Report Key: 5139029
• MDR Text Key: 27906078
• Report Number: 1226348-2015-00049
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 606S155X
• Device Lot Number: 16038288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 68