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	09/07/2021
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: 3005168196-2021-02192.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lumbar artery using pod packing coils (pod pc), ruby coil detachment handle (handle), and non-penumbra microcatheter.It was noted that the patient¿s anatomy was mildly tortuous.During the procedure, while advancing a pod pc through the microcatheter, the physician experienced resistance and the pod pc would not advance out the distal tip of the microcatheter.Subsequently, the physician attempted to detach the pod pc inside the microcatheter using a handle; however, the pod pc failed to detach.Consequently, after multiple attempts, the physician kinked the pusher assembly of the pod pc.Therefore, the pod pc was removed.The procedure was completed using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), an additional non-penumbra microcatheter, and the same carnelian hf 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: 12566506
• Report Number: 3005168196-2021-02193
• Device Sequence Number: 4080454
• Product Code: HCG
• UDI-Device Identifier: 00814548013268
• UDI-Public: 00814548013268
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2021
• 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: 06/13/2024
• Device Model Number: RH1-A
• Device Catalogue Number: RH1
• Device Lot Number: F107053
• 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: 09/09/2021
• Initial Report FDA Received Date: 10/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005