MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT GUIDE SHEATH, 6F, 45CM, STRAIGHT, HYDROPHILIC COATED; INTRODUCER SHEATH

Model Number	FG- 36045-001
Medical Device Problem Codes	Device-Device Incompatibility (2919); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of the incident is unknown at the time of the initial report.The complaint device will not be returned for an evaluation.The dhr review, which examines the dhr, ncrs, and ecos will be done as part of the root cause investigation.
Event or Problem Description
The customer reported as follows: catapult sheath had a hard time entering the 24f impella sheath.Device/procedure outcome: procedure - no information.As reported device codes: 1307: difficult to insert.As reported patient codes: 9398: no clinical signs, symptoms or conditions.Patient outcome: f24: insufficient information.
Additional Manufacturer Narrative
The complaint device was not returned for an evaluation.The complaint description is also not clear because the used impella sheath is intended to be used with other devices: more than one device at the same time as specified in impella® procedure with single-access technique procedural steps according to abiomeds brochure "impella procedure with single-acess teechnique.It could be one reason that the appropriate compatibility was not considered.However, no detailed information was received for the medical devices used in the operation other than 24f impella sheath.The hard insertion would be due to improper surface property.However, catapult sheath has hydrophilic coating that helps reducing frictions during the inserion if it is wetted.According to requested information by customer, the preparations before insertion of sheath were completed properly.According to the investigations done on batch record, ncrs, and ecos related to the complained lot, there is no event or deviation that can cause this defect failure mode.Root cause is undeterminable.

• Brand Name: CATAPULT GUIDE SHEATH, 6F, 45CM, STRAIGHT, HYDROPHILIC COATED
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• Manufacturer (Section G): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden 01277
• Manufacturer Contact: juliana nuernberger ; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 18814880
• Report Number: 3003637635-2024-00006
• Device Sequence Number: 8307813
• Product Code: DYB
• UDI-Device Identifier: 04251244502096
• UDI-Public: 04251244502096
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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 Expiration Date: 09/08/2026
• Device Model Number: FG- 36045-001
• Device Catalogue Number: US-36045-F-ST-H
• Device Lot Number: 752276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown