MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110; JCX

Catalog Number PMX110

Device Problems Occlusion Within Device (1423); Suction Problem (2170); Aspiration Issue (2883)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2015

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery using a penumbra system aspiration pump max 110.During the procedure, the physician turned on the pump max, however, it would not create suction.The physician was unable to aspirate using the pump max and the procedure continued using a syringe to aspirate.The syringe aspiration successfully cleared the m1, yet the m2 remained occluded.

Manufacturer Narrative

Conclusion: the device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Manufacturer Narrative

Prior to returning the pump to the manufacturer for evaluation, the distributor conducted their own device evaluation on the penumbra system aspiration pump max 110.During their evaluation, the vacuum cylinder was opened and a white, solid cream-like substance was observed and was suspected to be the cause of the suction issue.The distributor removed the white substance and re-assembled the motor and the pump began functioning normally with a vacuum level of 27 inhg.After the completion of the evaluation by the distributor, the device was returned to the manufacturer.The manufacturer found no visible damage to the exterior of the pump.According to the complaint, the pump did not work after the second use.Evaluation of the returned device post evaluation by the distributor, revealed that the pump was functional; however, due to the intervention (device evaluation) already carried out by the distributor, the root cause of the complaint cannot be determined and the complaint cannot be confirmed.These devices are 100% functionally tested during in-process inspection.Upon request by the manufacturer, a small sample of the white substance observed by the distributor during their evaluation of the device was sent to the manufacturer so that fourier transform infrared spectroscopy (ftir) could be performed; however, the ftir analysis was inconclusive.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 4492228
• MDR Text Key: 5327495
• Report Number: 3005168196-2015-00093
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor,distributor,forei
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX110
• Device Lot Number: F08202-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1