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

Model Number 406853

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event 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.

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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9835199
• MDR Text Key: 183565941
• Report Number: 3005334138-2020-00111
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734202985
• UDI-Public: 05414734202985
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ADVISOR¿ HD GRID MAPPING CATHETER, SE
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 88