MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MULTI-LUMEN/PSI KIT; INTERVENTIONAL PSI PRODUCTS

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.

• Brand Name: MULTI-LUMEN/PSI KIT
• Type of Device: INTERVENTIONAL PSI PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5986830
• MDR Text Key: 55999112
• Report Number: 1036844-2016-00514
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: MTO-11142-AJ
• Device Lot Number: 23F15F0973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1