MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL GMBH BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 45 CM, 6F CROSSOVER

Model Number	FG-06553-001A
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of the incident is unknown at the time of this report.The complaint device was not returned for evaluation yet, therefore the investigation and root cause analysis could not be performed.The dhr of the affected lot 632803 and related sub-assemblies lots 636794 and 635707 were reviewed without any non-conformities found.The devices passed all 100% in process and aql based qc inspections.The manufacturer informed manufacturing operators and qc inspectors about the complaint.The event has not caused any harm to the patient.No remedial actions were initiated at the time of this report.
Event or Problem Description
The following incident description was reported by the customer: "a fortress 6f introducer sheet was performing normally during a pta crossover intervention.During removal of the sheet the interventional physician (b)(6) had a hard time to complete the procedure.The sheet elongated itself and was finally removed in one piece.There was no complication to the patient or any parts remained in the body.".
Additional Manufacturer Narrative
Sample evaluation: the sample was returned for investigation.The reported elongation of the product was confirmed.The tip of the sheath was not damaged.The elongation of the sheath begins at approximately 2cm from the distal end, which is probably the spot which caused the friction.Od of the sheath was measured with ring gage used for inspection of 6fr (2,88mm) - the sheath passed through the ring gauge without any complications - it is confirmed, that the product was within the specification.According to the information provided by the customer, there were no difficulties during preparation and insertion of the sheath into the patient the customer informed cmi, that the dilator was not used during removal which is inconsistent with the instructions in ifu.The end user did not follow the instructions in the ifu - the dilator was not used during the removal, which is the most likely root cause.Other potential root causes could be e.G.Patient anatomy, failure of other devices used during the procedure etc.

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 45 CM, 6F CROSSOVER
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, germany 01277 ; GM 01277
• MDR Report Key: 7057617
• Report Number: 3003637635-2017-00001
• Device Sequence Number: 1131132
• Product Code: DYB
• UDI-Device Identifier: 04251244500092
• UDI-Public: 04251244500092
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K153197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2017

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: 05/31/2020
• Device Model Number: FG-06553-001A
• Device Catalogue Number: 386593
• Device Lot Number: 632803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 11/24/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR