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

Model Number RBYPCLP10

Device Problems Break (1069); Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

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 numbers: 3005168196-2020-02012; 3005168196-2020-02014; 3005168196-2020-02015.

Event Description

The patient was undergoing a coil embolization procedure in the lumbar artery using packing coil lps, ruby coil lps, and a non-penumbra microcatheter.During the procedure, the physician was unable to advance two packing coil lps, and two ruby coil lps within the introducer sheaths and experienced resistance.Upon attempting to pull back the packing coil lps and ruby coil lps, the packing coils and ruby coil lps broke inside the introducer sheaths.Therefore, the packing coil lps and ruby coil lps were removed.The procedure was completed using new ruby coil lps.There was no report of an adverse effect to the patient.

• Brand Name: PACKING COIL LP
• Type of Device: 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: 10848920
• MDR Text Key: 216697152
• Report Number: 3005168196-2020-02013
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00815948021914
• UDI-Public: 00815948021914
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K192955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYPCLP10
• Device Catalogue Number: RBYPCLP10
• Device Lot Number: F96815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR