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Catalog Number MTO-11142-AJ
Device Problem Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/25/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This product is not sold in the us. The 510k # provided is for a similar product that is sold in the us.
Event Description
The user reported that when the swan-ganz catheter was inserted into the cath-gard, the balloon of the catheter became damaged inside the cath-gard. As a result, a new kit was opened and used without issue. There was no reported delay, death, or complications to the patient as a result of this occurrence.
Manufacturer Narrative
(b)(4). Device evaluation: the report of difficulty inserting the balloon catheter into the cath-gard was confirmed. Returned was a cath-gard. This is a venous access kit labeled for use with 7. 5 - 8 fr catheters and does not contain a catheter. The swan-ganz catheter used by the customer was not returned and the size was not reported. The cath-gard had yellow connectors and the sterility tubing was extended. The cath-locks on both ends of the cath-gard were in the open position. The sterility tubing was folded back into its as shipped condition for evaluation. A 7. 5 fr edwards thermodilution (td) catheter from lab inventory was tested for balloon inflation and then was inserted through the cath-gard with minimal resistance. The balloon was tested and it inflated. It was inserted 2 more times and it inflated after both insertions. A 8. 0 fr edwards td catheter from lab inventory was then inserted into the proximal end of the cath-gard, but met significant resistance at the housing in the proximal cath-lock. It met minimal resistance when inserted into the distal housing of the cath-lock. The cath-locks at both ends of the cath-gard were disassembled for comparison since their internal parts are the same. The inner diameter (id) of the santoprene sleeve at the proximal end measured 0. 103" while the sleeve other remarks: at the distal end measured 0. 111" using pin gauges. The specification for this dimension (before assembly) is 0. 110 - 0. 117" per the sleeve graphic. The santoprene sleeves were removed from the housings and the cage in the housing holding the sleeve was measured. The outside diameter (od) "dim c" for the proximal housing measured 0. 307" while the distal housing measured 0. 315". The specification for this dimension is 0. 315 - 0. 319" per the housing graphic. The od "dim d" for the proximal housing measured 0. 2845" while the distal housing measured 0. 290". The specification for this dimension is 0. 288 - 0. 292" per the housing graphic. The measurements indicate that the opening in the proximal end of the cath-gard is smaller than that in the distal end and is below specification. Previous investigation has shown that this condition can be caused by leaving the cath-lock in the closed position after manufacture. This compresses the housing and the santoprene sleeve, which retains the compressed shape when the lock is opened for use. A review of the device history records for the cath-gard did not reveal any manufacturing related issues. The probable cause of this issue is manufacturing related. Further investigation of this complaint issue has been initiated.
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Manufacturer (Section D)
reading PA
Manufacturer (Section G)
312 commerce place
asheboro NC 27203
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5986830
MDR Text Key55999112
Report Number1036844-2016-00514
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2017
Device Catalogue NumberMTO-11142-AJ
Device Lot Number23F15F0973
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial