MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE PRECISION ACCESS SYSTEM; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that when the physician was trying to advance the ik sheath for a left heart catheterization (lhc) procedure via right groin access; he took the introducer out and left the wire, put the introducer back in to advance the sheath and then when he took the introducer out again, the wire broke off.Blood loss was reported to be less than 250cc.The patient was in stable condition, and the procedure was completed.Additional information was received on may 8, 2019.There was no harm to the patient; they were able to remove the broken wire segment.They continued the case with a second sheath successfully.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One 5fr introducer sheath, dilator, and guidewire were returned for product evaluation.Visual inspection revealed that there was a kink observed on the distal end of the sheath and a sharp bend was noted towards the distal end of the dilator.The guidewire was broken and a part of it was returned, which was visually examined under the microscope.The stiff end of the wire was measured to be 0.0205 inches using a vernier caliper which is within the manufacturer specifications.Functional testing was performed, and the failure was attempted to be replicated by bending the wire to check if it is brittle, the wire did not break upon bending.The fractured end surface was analyzed under a scanning electron microscope (sem).No evidence of fatigue fracture was observed.Per the supplier investigation; a review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested and was determined to be acceptable.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that that reported event was caused by the wire being caught up in the dilator bend region during withdrawal.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: PINNACLE PRECISION ACCESS SYSTEM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8640620
• Report Number: 1118880-2019-00114
• Device Sequence Number: 11331469
• Product Code: DYB
• UDI-Device Identifier: 00389701010885
• UDI-Public: 00389701010885
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K111606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 70-5165
• Device Lot Number: XD13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 47