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

Model Number	RBYPCLP10
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-01815.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat gastrointestinal (gi) bleeding using ruby coils, ruby coil lps, and a non-penumbra microcatheter.During the procedure, two ruby coil lps would not advance out of the introducer sheaths.Therefore, the ruby coil lps were removed.The procedure was completed using a new ruby coil lp.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned packing coil lp revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement and the device may not be advanced out of the introducer sheath.Forceful advancement against this resistance may have contributed to the kink and fracture near the pusher assembly mid-joint and the damage to the introducer sheath and the introducer sheath friction lock.Due to the pusher assembly fracture, the device could not be functionally tested.Further evaluation of the device revealed an additional pusher assembly kink.This damage was likely incidental to the complaint.Evaluation of the returned ruby coil lp revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement and the device may not be advanced out of the introducer sheath.Forceful advancement against this resistance may have contributed to the kinks near the pusher assembly mid-joint.During functional testing, the pusher assembly mid-joint was able to advance through the introducer sheath friction lock with resistance.Then the device was able to advance through its introducer sheath with additional resistance due to the kinks in the pusher assembly.Further evaluation of the device revealed additional pusher assembly kinks.This damage was likely incidental to the complaint.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: 1.3005168196-2021-01815.H3 other text : placeholder.

• Brand Name: PACKING COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12321984
• Report Number: 3005168196-2021-01814
• Device Sequence Number: 17177698
• Product Code: HCG
• UDI-Device Identifier: 00815948021914
• UDI-Public: 00815948021914
• Combination Product (Y/N): Y
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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): 10/01/2021
• 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: 01/11/2026
• Device Model Number: RBYPCLP10
• Device Catalogue Number: RBYPCLP10
• Device Lot Number: F103236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005