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

Catalog Number	400SMTSTD0725
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 104.0 cm from the proximal end.The pusher assembly was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the first returned smart coil revealed resistance when advancing the coil through the sheath.A foreign material was found on the proximal end of the sheath.This material likely contributed to the resistance experienced during initial testing.After decontamination, the returned device was able to advance through the sheath and a demonstration microcatheter without an issue.Further evaluation revealed kinks in the pusher assembly.These kinks may have occurred due to forceful advancement against resistance.Evaluation of the second 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, resistance may be encountered.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.While functionally testing the smart coil, resistance was encountered as the coil began to take shape inside the hub of the demonstration microcatheter.The offset coil winds likely contributed to the smart coil not being able to be advance through the non-penumbra microcatheter during the procedure.Further evaluation revealed a kink in the pusher assembly.This kink may have occurred due to forceful advancement against resistance during the procedure.Evaluation of the third returned smart coils revealed that the pusher assembly was retracted proximal to the introducer sheath friction lock.If the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock during use, resistance may be experienced while attempting to advance the pusher assembly during the procedure.While functionally testing the returned smart coil, resistance was encountered as the kinks in the pusher assembly were advanced through the demonstration microcatheter; however, the smart coil was advanced completely through the catheter and out of the distal tip.These kinks likely occurred due to forceful advancement against resistance during advancement.The non-penumbra microcatheter identified complaint was not returned for evaluation 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.This report is associated with mfr report numbers: 3005168196-2019-00888; 3005168196-2019-00889; 3005168196-2019-00891; 3005168196-2019-00892; 3005168196-2019-00893.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a ruptured aneurysm in the right posterior communicating artery (pcom) using penumbra smart coils (smart coils).During the procedure, the physician was unable to advance three smart coils out of their introducer sheaths and into a non-penumbra microcatheter; therefore, they were removed.It was reported that the physician attempted to advance one of the smart coils out of its introducer sheath on the back table, but it was unsuccessful.Next, the physician felt resistance while advancing three other smart coils through the microcatheter; however, the smart coils were able to be successfully implanted into the aneurysm.The procedure was completed using additional smart coils and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8584608
• Report Number: 3005168196-2019-00890
• Device Sequence Number: 16217370
• Product Code: HCG
• UDI-Device Identifier: 00814548014555
• UDI-Public: 00814548014555
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2019
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2023
• Device Catalogue Number: 400SMTSTD0725
• Device Lot Number: F81851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2019
• Initial Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 72
• Date Report Sent to FDA: 01/01/2005