MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA PROGREAT CATHETER; CATHETER, CONTINUOUS FLUSH

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted the actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code 11 has been referenced in the conclusions section of h6.A review of the device history record and the shipping inspection record of the involved product/lot# combination was conducted with no findings.A search of the complaint record did not find any other report with the involved product/lot# combination.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.
Event or Problem Description
The user facility reported that during an emergent coiling procedure, after 6 or 7 nestor coils were deployed, on the last coil deployment, the progreat device appeared to prolapse back on itself as the saline was used to shoot the coil forward.Upon further examination, it appeared that the inner coiling on the progreat device appeared to separate from the catheter itself and became lodged in the patients artery.The catheter remained otherwise intact however, the catheter coiling was still in the patient.It was left in the patient and the patient went on to surgery as originally scheduled.During this surgery, the surgeon removed the wire from the patient and sent the wire on to pathology.At this time, it is unsure if this wire is part of the progreat catheter inner coil, or if it is part of the primary wind of nestor coil.The patient was fine following the procedure.The procedure was successful and the bleeding was stopped.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date, and to cancel this report.It was determined based on the device return evaluation the reported event is not fda reportable.The actual device was returned for evaluation.Evaluation of the actual catheter sample revealed that the catheter tube had been partially elongated, however, it was confirmed that there was no fracture.No break or no missing part was found in the inner coil layer.From this , it is likely that the separated piece of "the inner coiling on the progreat" that lodged in the patient's artery was not from the actual catheter sample, but was possibly from a fractured embolization coil that was used in combination with the actual catheter sample.

• Brand Name: PROGREAT CATHETER
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 7497859
• Report Number: 9681834-2018-00084
• Device Sequence Number: 2052915
• Product Code: KRA
• UDI-Device Identifier: 04987350771773
• UDI-Public: 04987350771773
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K033913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: MC*PB2813Y
• Device Lot Number: 170614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NES TOR COILS (COOK); NES TOR COILS (COOK)
• Outcome Attributed to Adverse Event: Required Intervention