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

Model Number FG- 36045-001

Device Problems Device-Device Incompatibility (2919); Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2024

Event Type  malfunction  

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 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.

• Brand Name: CATAPULT GUIDE SHEATH, 6F, 45CM, STRAIGHT, HYDROPHILIC COATED
• Type of Device: 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
• MDR Text Key: 337735332
• Report Number: 3003637635-2024-00006
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1