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

Model Number	9-TV45X45-14F-080
Medical Device Problem Codes	Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 14f amplatzer torqvue 45x45 delivery sheath was found with burrs and cracks on the head section of the delivery sheath tip after removal from device packaging.There was no report of any damage to packaging box during device preparation.Upon discovery of the damage on the delivery sheath, a decision was made to replace with a second 14f amplatzer torqvue 45x45 delivery sheath to continue the procedure.The patient status was reported stable.
Event or Problem Description
It was reported that on (b)(6) 2025, a 14f amplatzer torqvue 45x45 delivery sheath was found with burrs and cracks on the head section of the delivery sheath tip after removal from device packaging.There was no report of any damage to packaging box during device preparation.Upon discovery of the damage on the delivery sheath, a decision was made to replace with a second 14f amplatzer torqvue 45x45 delivery sheath to continue the procedure.There was no patient contact with the first 14f amplatzer torqvue 45x45 delivery sheath.The patient status was reported stable.
Additional Manufacturer Narrative
It was reported that during preparation split in delivery sheath dilator noted.There were no adverse effects to the patient and the patient status was reported as stable.The dilator and sheath were returned to abbott and the investigation found that the tip of the dilator was noted to have a split cut damage.No other anomalies were found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the investigation findings, the dilator tip separation issue appears to be related to a potential product quality issue; therefore, exception issue 130010 was been initiated to further investigate this complaint.The primary root cause was related to the potential for medium density polyethylene and pebax to not homogeneously blend during melt processing.This potential relating to the material characteristics of the resin mix is the root cause of both the noted cracking and tearing with contributing causes of pebax material absorbing moisture and without sufficient drying steps prior to extrusion/shaping via heat, where the moisture could off gas and cause material voids, leading to structural weaknesses, leading to the potential for tearing during use when sufficient force is applied.Codes removed: medical device problem code: 2017 improper or incorrect procedure or method.Correction: manufacturing report 2135147-2025-01885, should not have been reported as a medical device report (mdr) as the event was noted during device preparation and did not make patient contact.

• Brand Name: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21821261
• Report Number: 2135147-2025-01885
• Device Sequence Number: 4288421
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)270131(10)10222946
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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 Model Number: 9-TV45X45-14F-080
• Device Catalogue Number: 9-TV45X45-14F-080
• Device Lot Number: 10222946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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
• Patient Age: 71 YR
• Patient Sex: Unknown
• Patient Weight: 63 KG