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

Catalog Number 400SMTHXSFT0102

Device Problems Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly and the coil had offset coil winds.Conclusions: evaluation of the returned device revealed that the smart coil embolization coil winds were offset.This type of damage typically occurs due to improper handling during use.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, resistance may be experienced and damage such as this may occur.The offset coil winds likely prevented the smart coil from being advanced within its introducer sheath and into the non-penumbra microcatheter.The smart coil was attempted to be advanced through a demonstration microcatheter.While attempt to advance the smart coil through the microcatheter; resistance was encountered as the coil offset coil winds bunched-up inside the introducer sheath and the smart coil could not be advanced any further.The non-penumbra microcatheter referred to in the complaint was not returned to penumbra 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 treating a gastrointestinal bleed using penumbra smart coils (smart coils).During the procedure, the physician advanced a smart coil into a non-penumbra microcatheter, however then removed the smart coil to reposition the microcatheter.Upon attempting to re-advance the same smart coil into the microcatheter, the physician experienced resistance and the smart coil became stuck and unable to advance within its introducer sheath.The procedure was therefore completed using a new smart coil.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: 7358350
• MDR Text Key: 103171835
• Report Number: 3005168196-2018-00623
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015613
• UDI-Public: 00814548015613
• 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: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/30/2022
• Device Catalogue Number: 400SMTHXSFT0102
• Device Lot Number: F75317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• 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