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

Model Number	LITNG12HTORQ115-A
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using an indigo system aspiration catheter 12 (cat12), a rotating hemostasis valve (rhv) and a guidewire.During the procedure, the physician completed two passes in the left pulmonary artery and retracted the cat12 to unclog it.The physician then attempted to re-advance the cat12 into the sheath, over the guidewire and turned the aspiration on; however, the rhv would not maintain a seal and full aspiration could not be performed.The physician also tried to troubleshoot the issue by tightening the rhv; however, the rhv could not be resealed, and the issue remained unresolved.Therefore, the rhv was removed.The procedure was completed using a new rhv.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12213002
• Report Number: 3005168196-2021-01640
• Device Sequence Number: 14235590
• Product Code: QEW
• UDI-Device Identifier: 00815948022577
• UDI-Public: 00815948022577
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210323
• 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
• Report Date (Section B): 07/22/2021
• 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: 02/09/2024
• Device Model Number: LITNG12HTORQ115-A
• Device Catalogue Number: LITNG12HTORQ115-A
• Device Lot Number: F103787
• Was Device Available for Evaluation?: No
• 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: 05/27/2021
• Initial Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Date Report Sent to FDA: 01/01/2005