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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier - requested, not provided, date of birth - requested, not provided, weight - requested, not provided, ethnicity - requested, not provided, race - requested, not provided, implanted date: device was not implanted, explanted date: device was not explanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record of the product code/lot# combination was conducted with no findings.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.- attachment: (b)(4).
Event or Problem Description
Per medwatch (b)(4) received by terumo: the patient presented with an intracranial hemorrhage and ct findings suggestive of an arteriovenous malformation.Patient underwent a diagnostic cerebral angiogram.During removal of the needle and wire, 1 cm of frayed wire was retained in the subcutaneous tissue.The patient had a history of hypoplastic left heart syndrome presenting with an intracranial hemorrhage.

• 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: 7309738
• Report Number: 1118880-2018-00009
• Device Sequence Number: 14015500
• Product Code: DYB
• UDI-Device Identifier: 00389701010762
• UDI-Public: 00389701010762
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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: 70-4160
• Device Lot Number: UP07
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 9 YR