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

Catalog Number 400SMTSFT0308

Device Problems Detachment Of Device Component (1104); Separation Failure (2547); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the returned smart coil revealed that the embolization coil winds were offset.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, damage such as offset coil winds may occur.Resistance was encountered as the smart coil embolization coil began to take shape inside the hub of the demonstration microcatheter and the smart coil could not be advanced any further.The non-penumbra microcatheter identified 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 in the basilar artery using penumbra smart coils (smart coils).During the procedure, the physician advanced a smart coil to the target location and attempted to detach it without using a smart coil detachment handle; however, the smart coil was unable to detach, despite the physician repositioning the smart coil and attempting multiple times.The physician, therefore, attempted to remove the smart coil, however, while retracting, the smart coil unintentionally detached within the proximal end of the non-penumbra microcatheter.The physician, therefore, removed the microcatheter with the smart coil inside and then completed the procedure using a new microcatheter and new smart coils.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: 7639751
• MDR Text Key: 112567229
• Report Number: 3005168196-2018-01273
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015057
• UDI-Public: 00814548015057
• 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: Physician
• Type of Report: Initial
• Report Date: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/04/2021
• Device Catalogue Number: 400SMTSFT0308
• Device Lot Number: F73014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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: 59 YR