MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿ SR SERIES, SR0¿ 8.5F; INTRODUCER, CATHETER

Model Number	406853
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturing reference: 3005334138-2020-00106.Following an atypical right atrial flutter procedure, an entanglement requiring snare removal occurred.When the sheaths and catheters were being removed from the patient, withdrawal difficulty was noted with the advisor catheter.Flouroscopy confirmed the catheter was caused in the distal end of the sheath.Manipulation of the catheter was attempted to release the catheter and sheared the introducer that was adjacent to the device in two pieces.The proximal portion of the sheath was removed, but a snaring tool was utilized to remove the distal portion of the sheath, which appeared to be fully removed from the vein.It was indicated by the physician that the advisor had wrapped around the sheath and became entangled.The patient was stable and the procedure was able to be completed.There was no damaged noted to the catheter.
Additional Manufacturer Narrative
One fast-cath guiding introducer swartz sr series, sr0 8.5f was received for investigation.The reported event of catheter withdrawal difficulty could not be confirmed.The sheath tube had been stretched and torn into two sections.The sheath hemostasis cap inside diameter measurement was within specifications; however, the sheath distal tip inside diameter could not be measured due to distal tip damage.Functional testing could not be conducted due to the condition of the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported catheter withdrawal difficulty remains unknown.The cause of the stretched and torn sheath tubing is consistent with damage during use.

• Brand Name: FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿ SR SERIES, SR0¿ 8.5F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9835199
• Report Number: 3005334138-2020-00111
• Device Sequence Number: 19554839
• Product Code: DYB
• UDI-Device Identifier: 05414734202985
• UDI-Public: 05414734202985
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 406853
• Device Catalogue Number: 406853
• Device Lot Number: 7075277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/27/2020
• 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: ADVISOR¿ HD GRID MAPPING CATHETER, SE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 88