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

Model Number LITNG12HTORQ115-A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Perforation (2001)

Event Date 11/09/2020

Event Type  Death  

Manufacturer Narrative

The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the indigo aspiration system include, but are not limited to, vascular complications (including vessel spasm, thrombosis, intimal disruption, dissection, or perforation), thromboembolic events, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

The patient was undergoing a thrombectomy procedure to treat a pulmonary embolism using an indigo system aspiration catheter 12 (cat12), lightning aspiration tubing (lightning), a non-penumbra sheath (cook flexor 12fr) and a guidewire (amplatz).During the procedure, the physician placed the sheath in the pulmonary artery, then advanced the cat12 through the sheath.The physician connected the lightning to the cat12 and initiated aspiration.During aspiration, the indicator light on the lightning unit turned yellow and the lightning and cat12 appeared to be occluded.The cat12 was removed to be flushed, but no thrombus was found.The lightning was disconnected and cleared.The physician then placed the cat12 back into the patient, and the cat12 occluded again.The cat12 was removed again, and the sheath was noticed to be occluded.Therefore, the sheath was removed and flushed, then placed back into the patient over the guidewire.An image was taken, and the physician discovered a perforation in the pulmonary artery.The procedure ended at this point.The patient was initially stable.Approximately twenty minutes later, the patient became unstable.The patient expired on the same day, and the patient's death was related to the perforation.It is unknown if the cat12 was in the patient at the time the perforation occurred.It is also unknown which device being used caused the perforation.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Type of Device: 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: 10972658
• MDR Text Key: 220393558
• Report Number: 3005168196-2020-02219
• Device Sequence Number: 1
• Product Code: QEW
• UDI-Device Identifier: 00815948022577
• UDI-Public: 00815948022577
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K200771
• 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: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LITNG12HTORQ115-A
• Device Catalogue Number: LITNG12HTORQ115
• 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
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR