MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 12; QEW

Model Number	SEP12-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2020
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using an indigo system separator 12 (sep12) and an indigo system aspiration catheter 12 (cat12).During the procedure, the physician experienced resistance while attempting to insert the sep12 through the rotating hemostasis valve (rhv) of the cat12, and subsequently, the sep12 was unable to advance through.Therefore, the sep12 was removed.The procedure was completed using the same rhv and the same cat12 without a sep12.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This report is associated with mfr report number: 3005168196-2020-01715.
Additional Manufacturer Narrative
Results: the sep12 was undamaged.The bulb was measured and was within specification.The returned rhv was untightened, but the seal inside the rhv would not open completely.Conclusions: evaluation of the returned sep12 confirmed that the device was unable to be advanced through the returned rhv.Further evaluation revealed that the seal inside the rhv would not open completely when the proximal end was loosened.The root cause of this damage could not be determined; however, this damage likely contributed to the resistance experienced during the procedure and the functional test.The separator bulb was measured and was within specification.Penumbra separators are 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.

• Brand Name: INDIGO SYSTEM SEPARATOR 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10439831
• Report Number: 3005168196-2020-01251
• Device Sequence Number: 3975245
• Product Code: QEW
• UDI-Device Identifier: 00815948021556
• UDI-Public: 00815948021556
• Combination Product (Y/N): Y
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K192981
• 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,Followup
• Report Date (Section B): 07/29/2020
• 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: 10/14/2022
• Device Model Number: SEP12-A
• Device Catalogue Number: SEP12
• Device Lot Number: F93679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 09/30/2020; 01/14/2005
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/30/2020; 10/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 68
• Date Report Sent to FDA: 01/01/2005