MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE 45X45 DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Model Number	9-TV45X45-14F-100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); Vascular Dissection (3160)
Date of Event	08/27/2021
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
It was reported that on (b)(6) 2021, a patient with coronary heart disease and cardiomyopathy was admitted to the hemodynamic room to perform an application closure with amplatzer device.During the surgery, the patient was sedated, intubated, and had their access site prepped.The access puncture was performed using an introducer with a needle and guide.Once the sheath was placed in the atrial appendage, the guidewire was changed for one with higher support and then continued with preparing the loading system.All this process was performed by the doctor.The vein was then pre-dilated and the sheath was introduced.After being advanced 3-4 cm, the dilator tip ended up fracturing.The sheath was removed, but the fractured part of the dilator tip remained in the vessel.After this, a dissection had to be made to be able to extract the fractured piece.The patient started to become hypotensive and desaturate due to blood loss.It took a long time to remove the tip of the sheath so it was decided to suspend the closure of the atrial appendage.The patient had to be transfused and went to an intubated intensive care unit (icu).Patient is stable.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h10.The dilator tip breaking off was confirmed.Investigation at abbott confirmed that the dilator tip was broken off.The cause of the tip detaching is inconclusive.Testing of the complaint device noted that the dilator appeared cut and detached, with subsequent testing revealing indications that the deformation matches a cut dilator with a sawing/scissors-like shear.This damage can potentially occur due to material defect or damage through handling in manufacturing or in preparation for the procedure itself.While a definitive cause wasn¿t able to be determined, there is no indication this damage was due to the manufacturing process and in process handling would have likely noted a separation as severe as was noted in analysis.Review of the lot records noted no observations for this issue or anything similar.The cause of the reported event could not be conclusively determined, however abbott is continuing to monitor this issue with monthly quality data reviews.

• Brand Name: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12547876
• Report Number: 2135147-2021-00383
• Device Sequence Number: 12051779
• Product Code: DQY
• UDI-Device Identifier: 00811806014111
• UDI-Public: 00811806014111
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K120120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2022

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: 01/31/2022
• Device Model Number: 9-TV45X45-14F-100
• Device Catalogue Number: 9-TV45X45-14F-100
• Device Lot Number: 6847750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male