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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH-LAB SHEATH INTRO SET:; INTERVENTIONAL PSI PRODUCTS
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ARROW INTERNATIONAL INC. CATH-LAB SHEATH INTRO SET:; INTERVENTIONAL PSI PRODUCTS Back to Search Results
Catalog Number CL-07611
Device Problem Decoupling (1145)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that while in the cath lab the md began the procedure and found that the sideport pulled away.As a result, the md removed it and used a new cath lab introducer sheath and completed the procedure successfully.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.
 
Manufacturer Narrative
(b)(4).Evaluation: no product was returned for evaluation.A device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint that the sidearm detached from the sheath is not able to be confirmed.The root cause of the complaint is undetermined.
 
Event Description
It was reported that while in the cath lab the md began the procedure and found that the sideport pulled away.As a result, the md removed it and used a new cath lab introducer sheath and completed the procedure successfully.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.
 
Manufacturer Narrative
(b)(4) device evaluation: returned for evaluation was a 6fr super arrow-flex (saf) sheath.Upon initial inspection the sidearm was noted not attached to the sheath hub.The sideport did not appear damaged upon visual inspection.The sidearm was able to be completely reattached to the sheath hub.The sidearm was not able to be pulled off with minimal force again.The sheath was inserted into the t-tube and pressurized to 200mmhg.The sheath and sidearm did not leak.A device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of sidearm separation is confirmed by visual inspection.The sidearm was returned detached from the valve body.The sideport and sidearm passed functional inspection after reconnection.The root cause of the separation is undetermined.
 
Event Description
It was reported that while in the cath lab the md began the procedure and found that the sideport pulled away.As a result, the md removed it and used a new cath lab introducer sheath and completed the procedure successfully.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.
 
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Brand Name
CATH-LAB SHEATH INTRO SET:
Type of Device
INTERVENTIONAL PSI PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX   31200
Manufacturer Contact
kathryn myers
2400 bernville road
reading, PA 19605
6103780131
MDR Report Key5143983
MDR Text Key28040369
Report Number9680794-2015-00118
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K924607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Physician
Type of Report Followup,Followup
Report Date 09/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCL-07611
Device Lot Number14F14F0275
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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