MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH-LAB SHEATH INTRO SET:; INTERVENTIONAL PSI PRODUCTS

Catalog Number CL-07645

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the event involved a patient 170cm in height.According to the user, the problem appeared to be in the proximal end of the dilator (near the hemostasis valve).During the insertion of the guidewire in the dilator (and the sheath) even though the guidewire was advanced easily for almost all the length of the dilator it found resistance and could not be advanced anymore 2 cm before exiting the proximal end of the dilator (near the valve).As a result, another cl-07645 catheter was used for the procedure.There was no reported patient death, injury or complications.There was a delay/interruption in therapy, described as a few minutes.

Manufacturer Narrative

(b)(4).The lot number reported is 14f16c0620.The lot number of the returned device is unknown.Returned for evaluation was a 6fr saf sheath and dilator without its original packaging.The dilator was fully inserted within the sheath; the dilator tip was approximately 6 cm from the sheath tip.The sheath hub and dilator hub appeared typical.The dilator tip and sheath tip appeared typical.No damage or abnormalities were noted.Some fluid was noted on the inside of the sheath sidearm.Very few specs of dried blood were noted on the exterior of the sheath.A lab inventory.025 in guidewire was successfully inserted through the dilator hub exiting the dilator tip, no resistance was noted.The guidewire was successfully inserted through the dilator tip exiting the dilator hub, no resistance was noted.No blood or debris was noted.The dilator was easily removed from the sheath.The dilator was re-inserted, locked and removed from the sheath successfully.The sheath was inserted into the t-tube and pressurized to 200 mmhg.The sheath and sidearm did not leak.See other remarks section.Other remarks: conclusion: the reported complaint of "dilator found resistance and could not be advanced" is not confirmed.The guidewire passed through the dilator successfully with no resistance.The device passed functional testing.The root cause of the complaint is undetermined.

Event Description

It was reported that the event involved a patient (b)(6) in height.According to the user, the problem appeared to be in the proximal end of the dilator (near the hemostasis valve).During the insertion of the guidewire in the dilator (and the sheath) even though the guidewire was advanced easily for almost all the length of the dilator it found resistance and could not be advanced anymore 2 cm before exiting the proximal end of the dilator (near the valve).As a result, another cl-07645 catheter was used for the procedure.There was no reported patient death, injury or complications.There was a delay/interruption in therapy, described as a few minutes.

• 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: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 6100315
• MDR Text Key: 59869435
• Report Number: 9680794-2016-00209
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K924607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: CL-07645
• Device Lot Number: 14F16C0620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2016
• 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
• Patient Age: 43 YR
• Patient Weight: 68