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

Catalog Number 400SMTHXSFT0103

Device Problems Kinked (1339); Failure to Advance (2524); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the embolization coil of the penumbra smart coil (smart coil) was intact with the pusher assembly and had offset coil winds.Conclusions: evaluation of the returned device revealed that the embolization coil had offset coil winds.This type of damage typically occurs if the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement.The offset coil winds prevented the smart coil from advancing out of its introducer sheath and into the returned non-penumbra microcatheter during functional testing.Penumbra coils are 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 to treat a basilar artery aneurysm using penumbra smart coils (smart coils).During the procedure, the physician placed three smart coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a new smart coil through the microcatheter, the physician did not have the introducer sheath of the smart coil completely seated into the hub of the microcatheter.Consequently, while attempting to advance the smart coil into the microcatheter, the tip of the coil became "kinked".Therefore, the smart coil was removed and the procedure was successfully completed using ten additional smart coils 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: 6958683
• MDR Text Key: 90568189
• Report Number: 3005168196-2017-01792
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015620
• UDI-Public: 00814548015620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2017

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: 05/10/2022
• Device Catalogue Number: 400SMTHXSFT0103
• Device Lot Number: F77045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2017
• 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: 61 YR