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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 20CM CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 20CM CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number EU-25853-CVT
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The preliminary evaluation of the returned device indicates swg/catheter resistance kinked. The device history record review showed no relevant findings.
 
Event Description
The customer reports the cvc cannot be threaded over the lying wire. A resistance is reported. A new device was used without issue.
 
Event Description
The customer reports the cvc cannot be threaded over the lying wire. A resistance is reported. A new device was used without issue.
 
Manufacturer Narrative
(b)(4). The customer returned a single 3-lumen catheter and a spring-wire guide (swg) for evaluation. Visual examination of the catheter did not reveal any defects or anomalies. Visual examination of the guide wire revealed two kinks in the swg body. The j-bend tip was undamaged and both of the welds were full, intact, and spherical. The two kinks in the swg were located approximately 237 mm and 244 mm from the proximal end of the swg. The length and outer diameter of the swg were measured and were found to be within specification. The proximal end of the returned guide wire was advanced through the distal end of the returned catheter to functionally test the components. The guide wire was able to advance through the catheter body but could not advance through the catheter juncture hub. When the guide wire was advanced from the distal extension line it was able to fully pass through the catheter and out of the catheter distal tip. All 3 extension lines on the catheter were flushed with water and functioned as expected. No sign of blockage or inter lumen crossover was observed. A pull test confirmed both the distal and proximal welds were intact. A device history record review was performed on the catheter and guide wire and no relevant manufacturing issues were identified. The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use. The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring-wire guide breakage. If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide. If resistance is again encountered, remove the spring-wire guide and catheter simultaneously. The reported complaint of difficulty passing the guide wire through the catheter was confirmed by complaint investigation. The swg was returned with two kinks and was unable to pass through the juncture hub of the returned catheter. A device history record review was performed with no relevant findings. Based on the sample received, it was determined that manufacturing caused or contributed to this event. A capa has been initiated to further investigate this issue.
 
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Brand NameARROW CVC SET: 3-LUMEN 8.5FR X 20CM
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7630700
MDR Text Key112171842
Report Number3006425876-2018-00419
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue NumberEU-25853-CVT
Device Lot Number71F18B0433
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

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