MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH CATAPULT, HYDROPHILIC COATED INTRODUCER SHEATH SYSTEM FINISHED GOOD 6FR 450MM

Model Number	FG-36045-001
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
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 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
It was reported by the physician as follows: "event description: it appears, that hub fractured.Patient present at time of event?: yes.Patient complications: no patient complication.
Additional Manufacturer Narrative
The device was returned for an evaluation.The returned product was double packed in an infecon pouch (2 plastic bag layers).The inner pouch was labelled with product information.Partial kinkage/breakage can be observed on the device.Also, the dilator was not inserted into the sheath as pictured by the customer.In addition, the failure occurred during mid procedure based on customer feedback and no power injectors were used during procedure.For the returned device, the dilator was inserted into the sheath.Upon inspection of the hva/sheath hub area, no clear evidence of breakage could be observed as the dilator kept the sheath straight.Only a minor bend/split was observed.The sheath assembly is a part of operation 10, according to manufacturing process plan mpp cfg-16000-001 - there is a forming device on which the inner and outer layers with the coil between are connected by using of hot air.The hub moulding process is a part of operation 50, according to the reference manufacturing process plan above.There is a visual inspection following after each manufacturing step.During final inspection are performed following tests: 100% leakage test, inner diameter (id) test by means of the pin, dimension test and strength test.The strength test is performed on the beginning and the end of production batch with minimal force requirement 15 n.The dhr review was performed by the device manufacturer.There is no indication that the complained event is manufacturing process related.Since the returned device had a partial bend, it does not seem likely any breakage occurred and kinking is most likely the failure mode; however, no further investigation could be done since the inserted dilator was keeping the sheath shaft material straight.Another potential source of sheath kinkage is the removal of the sheath with no dilator present which could result in sheath damage.Since the customer feedback was damage occurred during mid procedure, it is unlikely the damage resulted from misuse.On the other hand, during the review of manufacturing records, no ecos and ncr are found related to the failure mode.Therefore, the root cause is undeterminable.

• Brand Name: CATAPULT, HYDROPHILIC COATED INTRODUCER SHEATH SYSTEM FINISHED GOOD 6FR 450MM
• 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 ; GM 01277
• Manufacturer Contact: juliana nuernberger ; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 18532806
• Report Number: 3003637635-2024-00002
• Device Sequence Number: 20527800
• Product Code: DYB
• UDI-Device Identifier: 04251244502096
• UDI-Public: 04251244502096
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/18/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (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 Sex: Unknown