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

Model Number	SCH1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2021-02622 3005168196-2021-02623 3005168196-2021-02624 3005168196-2021-02626.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using penumbra smart coil detachment handles (handle), penumbra smart coils (smart coil), packing coil lps, a non-penumbra microcatheter, and a guidewire.During the procedure, the physician successfully detached a smart coil in the target vessel using a handle.The physician then advanced another smart coil to the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach after multiple attempts.Therefore, the smart coil was removed.Next, the physician successfully detached a packing coil lp in the target vessel using a second handle.The physician then advanced another packing coil lp to the target vessel and attempted to detach it using the handle; however, the packing coil lp also failed to detach after multiple attempts.Therefore, the packing coil lp was removed.Then, the same issue occurred with another packing coil lp.It was reported that a second attempt made to detach the packing coil lp with the first handle was also unsuccessful.Therefore, the physician manually detached the packing coil lp.The procedure was completed at this point as the physician lost access.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL DETACHMENT HANDLE
• Common Device Name: 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: 12841364
• Report Number: 3005168196-2021-02625
• Device Sequence Number: 14541108
• Product Code: HCG
• UDI-Device Identifier: 00814548016139
• UDI-Public: 00814548016139
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2021
• 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 Model Number: SCH1
• Device Catalogue Number: SCH1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 10/24/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005