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

Model Number	RH1-A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
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 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: 3005168196-2021-01643.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left pulmonary artery using pod coils, a ruby coil detachment handle (handle) and a non-penumbra microcatheter.During the procedure, while loading a pod coil into a microcatheter, the new resident kinked the pod coil.Therefore, the pod coil was removed.Next, the physician successfully deployed and detached three penumbra coils in the target location using the microcatheter.The physician then advanced another penumbra coil into the target location and attempted to detach it using the handle; however, the penumbra coil failed to detach.Therefore, the physician used a new handle to detach the penumbra coil.The procedure was completed using a new pod coil, the second handle and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12218158
• Report Number: 3005168196-2021-01644
• Device Sequence Number: 3962443
• Product Code: HCG
• UDI-Device Identifier: 00814548013268
• UDI-Public: 00814548013268
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 07/23/2021
• 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 Expiration Date: 04/18/2024
• Device Model Number: RH1-A
• Device Catalogue Number: RH1
• Device Lot Number: F105473
• Was Device Available for Evaluation?: No
• 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: 06/28/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Date Report Sent to FDA: 01/01/2005