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

Model Number	FG-06551-001A
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	07/04/2018
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 review of the complaint lot 638952 and related subassemblies lots 638052 and 640154, there was no deviation found in the records.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 customer initially provided cmi (manufacturer) with the following problem description on 07/11/2018: at the end of the procedure when the dr was withdrawing the sheath, there was resistance and the patient was complaining of 10/10 pain.As he continued to withdraw the sheath it appeared to "unravel".Pt required further analgesia and imaging to ensure that no remnants were left in the patient.On 07/18/2018, the customer provided cmi with additional information: i had a further conversation with the dr yesterday.The patients groin was very scarred and had a venous bypass graft.It tracked ok on introduction to the artery via the bypass.It was on withdrawal that the resistance was encountered.They noticed that the sheath was withdrawing (or appeared to be) but on imaging the distal opaque marker was not moving.This is when he realised that the sheath was uncoiling or "stretching" due to the resistance.He did reintroduce the dilator, however the sheath had stretched so the dilator did not reach the distal tip.It did help to withdraw the sheath further.He did require to use artery forceps to get enough traction or "grip " on the sheath to withdraw fully and this is when the sheath split into 2.He is confident that there was no parts of the sheath left in the patient.The additional information caused re-assessment of the reportability of this event.Note: the dilator was not used since the beginning of withdrawal, it was re-inserted at the time when the doctor felt the resistance.
Additional Manufacturer Narrative
Sample evaluation: after the return of the sample, prior to the investigation the sample was sent to the external laboratory for decontamination the returned sheath was inspected and physical damage was confirmed.The outer sheath broke which exposed the inner metal reinforcement.The tip section itself showed no sign of damages.Complaint investigation information: the customer provided cmi with information, that the dilator was not in place while the retraction of the sheath began.This is a violation of instruction in ifu, section precautions.Another violation of ifu, section warnings, was that the end user continued with withdrawing of the introducer despite the resistance without determining the cause.The factors possibly contributing to the incident: as was reported by the customer the patient has calcified lesion and the lesion length was 150mm - it is possible that the sheath got stuck in the calcified lesion; the vessel vasoconstricted (due to a vessel spasm) and therefore the introducer sheath was hard to remove from the patient.Root cause: the root cause of the incident is most likely end user error - did not follow the instruction in ifu, together with the patient conditions/anatomy attachment: (b)(4).

• Brand Name: BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 45CM, 6F STRAIGHT
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL GMBH; lauensteiner strasse 37; dresden, germany 01277 GM; GM 01277 GM
• MDR Report Key: 7766890
• Report Number: 3003637635-2018-00001
• Device Sequence Number: 227933
• Product Code: DYB
• UDI-Device Identifier: 04251244500078
• UDI-Public: 04251244500078
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

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: 08/31/2020
• Device Model Number: FG-06551-001A
• Device Catalogue Number: 386594
• Device Lot Number: 638952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 09/06/2018
• 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: 75 YR