MAUDE Adverse Event Report: ONSET MEDICAL CORPORATION SOLO PATH RE-COLLAPSIBLE ACCESS SYSTEM; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	09/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - height: (b)(6) cm.The actual device has been returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The user facility reported similar events from the same product code/lot number combination.See mdr 3004672932-2017-0008.A review of the device history record of the product code/lot# combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product code/lot# combination.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported that after introduction they could recognize a nick at the sheath.The following information was provided by the user: physician could introduce the ivac catheter over the nick into the aorta without any problems.It was reported that the patient was high risk.It was reported that the patient condition was stable.It was reported that the blood loss was about 500 ml during pci.Additional information was received on 9/19/17: both solopaths reported (0870 and 0871) had been in the same patient, while the same procedure.Both of them have had a kinking.A few days before, the patient had an acute myocardial infarction.While an angio the physician diagnosed a three vessel chd with multiple stenosis and a low ef.Because of that, it was a high risk pci.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to correct section: catalog # and to provide the completed investigation.It was initially reported as stfi-1935; however, it has been confirmed that was incorrect.Sections have been updated to reflect this information.One 19 fr re-collapsible solopath sheath was received for product analysis.After decontamination, the device was subjected to visual analysis where a blood-like substance was observed the sheath and hub.The balloon dilator the sheath was sold with was not returned.The sheath appeared partially collapsed with a shallow u shape.No gross visual anomalies were noted with the outer jacket.No kinks were observed in the sheath.Functional testing was then undertaken to determine if any microscopic holes existed in the outer jacket.The outer jacket of the sheath was then inflated to 6atm to observe for any holes.After 30 seconds no holes were identified.Due to the balloon dilator not being returned and the sheath being collapsed, no functional testing could be performed to measure the inner diameter of the sheath or examine the inner lumen for any anomalies.The re-collapsed sheath indicated that the sheath had once had the inner diameter enlarged.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: SOLO PATH RE-COLLAPSIBLE ACCESS SYSTEM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ONSET MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 6940964
• Report Number: 3004672932-2017-00009
• Device Sequence Number: 18998056
• Product Code: DYB
• UDI-Device Identifier: 00852381004357
• UDI-Public: 00852381004357
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2017

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: 06/30/2018
• Device Model Number: N/A
• Device Catalogue Number: SR-1935
• Device Lot Number: UK03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 80