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

Catalog Number 400SMTHXSFT0208

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was detached from its pusher assembly, stuck inside the proximal end of its introducer sheath, and had offset coil winds.The smart coil embolization coil was detached from its pusher assembly and, therefore, the smart coil could not be functionally tested.Conclusions: evaluation of the returned smart coil revealed that the embolization coil was detached from its pusher assembly.If the device is forcefully retracted against resistance, damage such as the embolization coil detaching may occur.Further evaluation revealed that the embolization coil winds were offset on the proximal end of the embolization coil inside the sheath.These offset coil wind may have contributed to the resistance prior to the embolization coil detaching from its pusher assembly and prevented the smart coil from advancing out of its sheath during the procedure.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 to treat multiple aortopulmonary collateral arteries (mapcas) using penumbra smart coils (smart coils).During the procedure, the physician deployed and detached seven smart coils and seven pc400s in the target vessel using a non-penumbra microcatheter.The physician then connected the introducer sheath of another smart coil to the hub of the microcatheter and attempted to advance the smart coil into the hub of the microcatheter; however, the smart coil became stuck and would not advance out of its introducer sheath.Therefore, it was removed.The physician then attempted to pull the smart coil out of its introducer sheath and insert it into another introducer sheath; however, the smart coil detached from its pusher assembly.The procedure was completed using five 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: 7894299
• MDR Text Key: 120969435
• Report Number: 3005168196-2018-01869
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015996
• UDI-Public: 00814548015996
• Combination Product (y/n): Y
• 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: 01/01/2005,08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2022
• Device Catalogue Number: 400SMTHXSFT0208
• Device Lot Number: F78839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2017
• 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: 1 YR