MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 7D; QEW

Catalog Number	SEP7D
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Hold for mb 10.13 the patient was undergoing a thrombectomy procedure in the brachial artery using an indigo system separator 7 d (sep7 d) and an indigo system aspiration catheter 7 d (cat7 d).During the procedure, after completing the first pass, the physician removed the cat7 d and sep7 d and noticed under fluoroscopy that the wire distal to the bulb of the sep7 d had migrated from the patient''s arm into the lung.The procedure ended at this point and no further intervention was performed to remove the foreign body.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Additional 510(k)# that also apply to this complaint: k210083.This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up #01 mfr report: 3005168196-2022-00427.1.Section h.Box 6.Device code 2.Evaluation of the returned sep7d confirmed that the tip distal to the bulb was fractured off the delivery wire.If the sep7d is repeatedly manipulated through tough clot burden, the distal tip may become fatigued and damage such as this may occur.The fractured distal tip was not returned for evaluation.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.H3 other text : placeholder.

• Brand Name: INDIGO SYSTEM SEPARATOR 7D
• Common Device Name: QEW
• 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: 15414465
• Report Number: 3005168196-2022-00427
• Device Sequence Number: 12172408
• Product Code: QEW
• UDI-Device Identifier: 00815948023994
• UDI-Public: 815948023994
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K193595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022
• 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: 12/20/2024
• Device Catalogue Number: SEP7D
• Device Lot Number: H12300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005