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

Model Number	400SMTHXSFT0306
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-01163.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician implanted a series of smart coils in the aneurysm.While attempting to push the last two smart coils separately out of the introducer sheath, the smart coils would not advance from the initial position.Therefore, the smart coils were removed.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 137.5 and 138.0 cm from its proximal end.The pusher assembly mid-joint was proximal to the introducer sheath friction lock.The embolization coil was intact with its pusher assembly and undamaged.Conclusions: evaluation of the first smart coil 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, and the smart coil may not advance within its introducer sheath.If the device is forcefully advanced against this resistance, damage such as a kink in the pusher assembly may result.During the functional test, resistance was encountered while attempting to advance the smart coil from its returned position.The smart coil was retracted from its pusher assembly an attempted to be re-sheathed properly.However, resistance was encountered due to the kink in the pusher assembly, and the introducer sheath could not be advanced any further.Therefore, the smart coil could not be functionally tested.Evaluation of the second smart coil 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, and the smart coil may not advance within its introducer sheath.If the device is forcefully advanced against this resistance, damage such as a kink in the pusher assembly may result.During the functional test, resistance was encountered while attempting to advance the smart coil from its returned position.The smart coil was retracted from its pusher assembly an attempted to be re-sheathed properly.However, resistance was encountered due to the kink in the pusher assembly, and the introducer sheath could not be advanced any further.Therefore, the smart coil could not be functionally tested.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.This report is associated with mfr report number: 3005168196-2020-01163.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10382991
• Report Number: 3005168196-2020-01164
• Device Sequence Number: 16879340
• Product Code: HCG
• UDI-Device Identifier: 00814548015781
• UDI-Public: 00814548015781
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 07/17/2020
• 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: 03/31/2025
• Device Model Number: 400SMTHXSFT0306
• Device Catalogue Number: 400SMTHXSFT0306
• Device Lot Number: F97128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 08/08/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005