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Model Number 0052-3025
Device Problems Backflow (1064); Kinked (1339)
Patient Problems Hematoma (1884); Hemostasis (1895); Blood Loss (2597)
Event Date 11/29/2017
Event Type  Injury  
Manufacturer Narrative
A review of device history record (dhr) was conducted and there were no manufacturing rejects or anomalies recorded in the dhr affecting released product. The sheaths released to inventory passed all in-process and qa final inspection steps before shipping to the customer, customer including visual, dimensional and leak testing. As per the procedure, adelante s2s introducer sheath in-process and final inspection, it instructs "with naked eye at a distance of 12" to 18", verify the assembled sheath matches the drawing. Ensure parts are free of kinks, cracks, splits, sinks, excessive flash, loose/embedded fm, or any other damages. " as the procedure introducer set, silicone seal slitting states, "the operator visually inspects all the slit seals for defects 100 percent with a microscope. Also, a leak test is performed on 100 percent of the introducer sheaths by qa per the leak test - introducer with seal- electronic tester procedure. Two 14f abiomed introducer sheaths, one 13 cm and one 25 cm in length were returned from the customer along with one 33 cm long dilator. There were no other accessories. Blood was found on all components. Upon evaluation of the 25 cm long sheath, there was damage found around the circumference of the distal tip edge that looked like a bend/kink as stated in the complaint. The distal tip of the 33 cm dilator is curved as well. Putting any excessive stress on the sheath may cause it to kink, deform or break. It is believed the sheath and dilator were subjected to stresses beyond their capabilities during use out in the field. Upon evaluation of the 13 cm long sheath, it was found that the insertion point into the hemostasis valve was identified to be considerably off center of the helical cuts, creating a hole in the valve. This caused the blood to ooze out of the hemostasis valve. It is stated in the instructions for use (ifu) never advance or withdraw guidewire or sheath when resistance is met. Determine cause by fluoroscopy and take remedial action. When injecting or aspirating through the sheath, use the sideport only. It also indicates "when assembling the sheath and dilator, care must be taken to insert the dilator tip straight through the center of the valve membrane in order to prevent inadvertent puncturing of the membrane. " returned device analysis reveals two 14f introducer sheaths and one dilator that are within manufacturing specifications. The reason for return cannot confirmed. No manufacturing defects were found. Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity. In addition, there was no new failure mode identified and the risk remains acceptable for both events reported. The event will be re-evaluated if additional information becomes available. Oscor will continue to monitor this event type and risk.
Manufacturer Narrative
Conclusion not yet available, evaluation in process. This initial mdr is being submitted to meet our requirements of reporting. A follow-up will be submitted as soon as the investigation is complete.
Event Description
There was a complaint made yesterday (b)(6) 2017, regarding an oscor introducer/impella support case. What is the date of event? (b)(6) 2017. What is the name of the facility where event occurred? (b)(6) hospital, (b)(6). What is the outcome of the patient? (e. G. Patient stable, patient alive, no injury, serious injury, death) patient is stable. What procedure was the product used for? implant of the impella cp what was the condition of the patient when presented to the physician? the patient was admtited for a high risk percutaneous coronary intervention (pci) for a chronic total occlusion of the right coronary artery (rca). Was there an issue with the product ? if yes , then provide details of the issue and answer the questions a) and b). There was a bend/kink at the tip of the 14x25 introducer. They then placed the 14x13 introducer and there was a constant ooze at the diagphragm. Awaiting more case particulars about the amount of blood lost from the ooze and the resulting hematoma. When was the issue identified? (before, during or after the procedure) during. What was the user (physician/ doctor/ nurse) doing when the issue occurred? placement of the 2 introducers. Please provide the contact information of the physician who used the product to obtain additional clinical information of the event in question. N/a what is the model number and lot no. Of the device used? both the 14x25 and 14x13 were used (b)(4). Was there any additional devices used during the procedure? when the case was completed the arterial closure device failed, and so the groin access site had a competitor's 14x30 introducer placed until hemostasis could be achieved. In which sequence the devices were used if multiple devices were involved? serial dialtions, 14x25, 14x30, impella cp, arterial closure device, a competitor's 14x30. Are the devices available to return to the manufacturer for evaluation? product has been requested from the field but, not yet returned. Received additional information on (b)(6) 2017: what is the age, sex, and initials of the patient? the patient is a (b)(6) male. Did the patient experience any extended hospitalization? if yes, please provide details. Will enquire regarding the patient discharge etc. What date was the pump explanted? (b)(6) 2017. Customer still inquiring about amount of blood loss.
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Manufacturer (Section D)
3816 desoto blvd.
palm harbor FL 34683 1816
Manufacturer (Section G)
3816 desoto blvd.
palm harbor FL 34683 1816
Manufacturer Contact
dorit segal
3816 desoto blvd
palm harbor, FL 34683-1816
MDR Report Key7131732
MDR Text Key255763646
Report Number1035166-2017-00112
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/01/2020
Device Model Number0052-3025
Device Catalogue Number0052-3025
Device Lot NumberC1-13629
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/19/2017 Patient Sequence Number: 1