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

Model Number 400SMTHXSFT2H06

Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician implanted two smart coils in the target vessel using the microcatheter.While advancing the next smart coil in the introducer sheath, the physician experienced resistance, and the pusher assembly of the smart coil broke and kinked.Therefore, the smart coil was removed.The procedure was completed using thirteen other smart coils and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 137.0 and 139.0 cm from the proximal end.The pusher assembly was fractured approximately 138.0 cm from its proximal end.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was detached from its pusher assembly inside its introducer sheath.Conclusions: evaluation of the returned smart coil confirmed a pusher assembly fracture and revealed that the pusher assembly mid-joint was proximal to the introducer sheath friction lock.If the pusher assembly mid-joint is proximal to the introducer sheath friction lock, resistance may be encountered upon advancement.If the device is forcefully advanced against this resistance, damage such as a kink and subsequently fracture may occur.Further evaluation of the returned smart coil revealed kinks in the pusher assembly and a detached embolization coil.The kinks likely resulted from forceful advancement against resistance during the procedure.The detached embolization coil was likely a result of the pusher assembly fracture.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.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10379583
• MDR Text Key: 202046706
• Report Number: 3005168196-2020-01129
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015767
• UDI-Public: 00814548015767
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2022
• Device Model Number: 400SMTHXSFT2H06
• Device Catalogue Number: 400SMTHXSFT2H06
• Device Lot Number: F78130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• 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: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR