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

Device Problems Unraveled Material (1664); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2019

Event Type  malfunction  

Event Description

During its post-market surveillance activities on (b)(6) 2022, penumbra inc.Became aware of a journal article titled, "migration of nonfibered packing coils used to treat peripheral pseudoaneurysms: report of 3 cases" (gonzalez-araiza et al.2019).This article reports three cases of penumbra coil migration into the lumens of adjacent viscera: two into the duodenum and one into the vagina.In the second case study, the physician used two pod coils (4mm and 5mm), three pod packing coils (pod pcs) (one 30cm and two 15cm), and one ruby coil (3mm x 15cm) to treat a recurrent pseudoaneurysm by embolizing the right hepatic artery (rha) and gastroduodenal artery (gda) stump.One-month post-procedure, the computed tomography (ct) scan showed migration and unraveling of the packed coil mass into the adjacent duodenum.Endoscopic removal to prevent retrograde infection of the second intact coil mass was performed.No bleeding or retrograde infection were evident one month after endoscopic removal.It was not possible to ascertain specific device information from the article, nor to match the events reported with previously reported complaints.Therefore, this report addresses all malfunctions and/or adverse events within this literature source.

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: 3005168196-2022-00068, 3005168196-2022-00069, 3005168196-2022-00070, 3005168196-2022-00071, 3005168196-2022-00072.

• Brand Name: RUBY COIL
• 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: 13579669
• MDR Text Key: 288628960
• Report Number: 3005168196-2022-00073
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 47 YR
• Patient Sex: Male