MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Catalog Number 400SMTHXSFT0204

Device Problems Stretched (1601); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the penumbra smart coil (smart coil) pusher assembly.The embolization coil was intact with its pusher assembly.The embolization coil had offset coil winds.During functional analysis, the smart coil was attempted to be advanced through a demonstration microcatheter; however, resistance was encountered as the offset coil entered the proximal end of the demonstration microcatheter and the smart coil could not be advanced any further.Conclusions: evaluation of the returned device revealed that the smart coil embolization coil had offset coil winds.This type of damage typically occurs due to improper handling during use.If the introducer sheath is not properly aligned inside the hub of the microcatheter prior to advancement, offset coil winds may occur.The offset coil winds likely contributed to the resistance that was experienced when the tip of the coil was passing through the hub during the procedure and functional testing.The root cause of the microcatheter kicking out of the aneurysm could not be determined.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure in the cerebral artery using penumbra smart coils (smart coils).During the procedure, the physician advanced a non-penumbra microcatheter into the target vessel, then placed one non-penumbra coil and three smart coils.While the physician was attempting to advance a new smart coil through the microcatheter, the microcatheter kicked out of the aneurysm.Therefore, the physician removed both the smart coil and the microcatheter.Next, the smart coil was rinsed in a saline bath and the microcatheter was re-advanced into the aneurysm.While attempting to re-advance the same smart coil into the microcatheter, the physician encountered resistance when the tip of the coil was passing through the hub of the microcatheter.The smart coil introducer sheath containing the smart coil was then removed without an issue.However, upon inspection of the smart coil, it was noticed that the coil had become "stretched".Therefore, the procedure was completed using a new smart coil and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7136280
• MDR Text Key: 95905276
• Report Number: 3005168196-2017-02223
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015712
• UDI-Public: 00814548015712
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2017

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: Physician
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 400SMTHXSFT0204
• Device Lot Number: F74152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR